Pfizer
Cardiovascular symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | chest discomfort |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2021-01-01 | palpitations |
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved...
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Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.
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| 40 | 2021-01-03 | blood pressure fluctuation, chest discomfort |
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug...
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Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
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| 40 | 2021-01-03 | chest discomfort |
Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximate...
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Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration
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| 40 | 2021-01-03 | lightheadedness |
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak...
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I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
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| 40 | 2021-01-04 | heart rate increased |
12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm...
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12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.
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| 40 | 2021-01-04 | blood pressure increased |
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ...
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Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
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| 40 | 2021-01-05 | fast heart rate |
Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tach...
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Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.
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| 40 | 2021-01-05 | chest discomfort |
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t...
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Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
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| 40 | 2021-01-05 | chest discomfort, heart rate increased |
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R...
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Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
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| 40 | 2021-01-05 | fainting, loss of consciousness |
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d...
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Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
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| 40 | 2021-01-05 | palpitations, pallor |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-06 | heart rate irregular |
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou...
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I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
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| 40 | 2021-01-06 | hypertension, palpitations |
Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 9...
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Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.
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| 40 | 2021-01-07 | loss of consciousness |
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re...
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Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
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| 40 | 2021-01-07 | chest discomfort |
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra...
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After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
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| 40 | 2021-01-07 | loss of consciousness |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | fast heart rate, hypotension |
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later wit...
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Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
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| 40 | 2021-01-07 | heart rate increased, heart rate increased |
Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then c...
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Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.
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| 40 | 2021-01-07 | chest discomfort |
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal...
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Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
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| 40 | 2021-01-07 | chest discomfort, palpitations, fast heart rate |
Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and ...
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Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.
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| 40 | 2021-01-07 | chest pain | Severe Headaches Body aches Fatigue Chest pain allergies worsened |
| 40 | 2021-01-08 | chest discomfort |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | chest discomfort, heart rate increased |
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE...
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11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
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| 40 | 2021-01-08 | palpitations | Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine. |
| 40 | 2021-01-08 | fast heart rate | dizziness, fever, chills, tachycardia > 90 bpm |
| 40 | 2021-01-09 | palpitations, pallor |
After sitting down in the observation area and I was just starting to register for vsafe my heart st...
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After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.
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| 40 | 2021-01-09 | chest pain |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-10 | chest discomfort |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | fast heart rate |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | palpitations |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | heart rate increased |
Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was ab...
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Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was able to lay down in the vehicle as we were traveling from home to location and after about 5-10 minutes of laying back my HR lowered to between 100-120; arrived at ED around 6:45 and while waiting 4 hours in waiting rom area to be seen HR remained around 110-115 for the 4 hours straight and finally after about 5-6 hours it retuned to normal rate.
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| 40 | 2021-01-10 | body temperature decreased |
Started out with my shoulder blades being sore that night. I woke up the next morning and was sore a...
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Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.
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| 40 | 2021-01-10 | fast heart rate, blood pressure increased | Tongue swelling, headache, tachycardia, elevated BP |
| 40 | 2021-01-10 | fainting |
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasova...
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Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.
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| 40 | 2021-01-10 | heart rate increased | c/o rapid pulse, anxiousness |
| 40 | 2021-01-10 | fainting, chest discomfort, very slow heart rate, hypertension |
lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine ...
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lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours
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| 40 | 2021-01-10 | chest pain | pinching type of chest pain |
| 40 | 2021-01-11 | chest pain |
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021...
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lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
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| 40 | 2021-01-11 | chest discomfort |
shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (...
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shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-12 | lightheadedness, fast heart rate |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | heart rate increased | Systemic: increased heart rate-Mild; symptoms lasted 0 days |
| 40 | 2021-01-12 | chest discomfort, chest pain |
This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablat...
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This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.
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| 40 | 2021-01-13 | heart rate increased |
EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-11...
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EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
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| 40 | 2021-01-13 | fast heart rate, palpitations |
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio...
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Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
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| 40 | 2021-01-13 | palpitations |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-13 | fast heart rate |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
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| 40 | 2021-01-13 | chest discomfort |
onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling w...
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onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.
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| 40 | 2021-01-14 | lightheadedness |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | chest discomfort |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-14 | fast heart rate, chest discomfort | Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning. |
| 40 | 2021-01-14 | palpitations, blood pressure fluctuation, heart rate increased |
Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach c...
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Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.
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| 40 | 2021-01-14 | fainting |
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine....
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Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
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| 40 | 2021-01-14 | heart rate increased | Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching |
| 40 | 2021-01-14 | fainting |
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I...
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partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 40 | 2021-01-17 | chest discomfort |
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. G...
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1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
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| 40 | 2021-01-17 | hypotension, fast heart rate |
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ...
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Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
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| 40 | 2021-01-17 | chest discomfort |
Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her...
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Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.
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| 40 | 2021-01-17 | loss of consciousness |
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled ...
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employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.
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| 40 | 2021-01-18 | heart rate increased |
3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some ...
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3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-01-18 | chest pain | Back pain, headache, joint pain, weakness, fever, chest pain. |
| 40 | 2021-01-18 | pallor |
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat...
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During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.
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| 40 | 2021-01-18 | palpitations | Lightheaded, felt like passing out, intermittent palpitations |
| 40 | 2021-01-18 | chest discomfort | Reported chest tightness. |
| 40 | 2021-01-18 | blood pressure increased |
Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue starte...
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Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.
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| 40 | 2021-01-18 | chest pain |
patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other as...
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patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other associated symptoms. Vital signs normal. Evaluated in Emergency Dept. Discharged. Note that patient was very anxious prior to and after vaccination.
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| 40 | 2021-01-19 | chest pain |
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le...
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Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-19 | chest discomfort, palpitations |
Patient presented for evaluation of an episode of chest tightness and possible allergic reaction aft...
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Patient presented for evaluation of an episode of chest tightness and possible allergic reaction after receiving the Pfizer vaccination for COVID-19. Patient reports that she initially did well but while she was waiting the 15 minutes of observation after the vaccine she began to note intermittent chest tightness as well as feeling like her heart was racing. This may have represented an allergic reaction although she did not require any medication to treat it.
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| 40 | 2021-01-19 | vaginal haemorrhage |
Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy...
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Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy was entirely normal up to that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently delivered at 18 weeks. Baby was stillborn. Ultrasound done 1/15/2021 normal. Lethal event for the fetus. The patient did well.
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| 40 | 2021-01-19 | heart rate abnormal, chest pain, chest discomfort |
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both...
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Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
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| 40 | 2021-01-20 | blood pressure increased |
2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose admi...
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2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered. Information on the Lot/Batch number has been requested.
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| 40 | 2021-01-20 | chest pain |
Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest...
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Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.
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| 40 | 2021-01-20 | fast heart rate, fast heart rate, fast heart rate |
My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't...
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My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.
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| 40 | 2021-01-21 | heart rate decreased, heart rate increased, heart rate irregular |
After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart ...
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After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.
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| 40 | 2021-01-22 | chest discomfort | 1/19 arm sore 1/20 achy 1/22 tightness in chest |
| 40 | 2021-01-22 | palpitations |
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak...
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Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
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| 40 | 2021-01-23 | oxygen saturation decreased | Fever, headache, chills, cough, congestion, lower oxygen levels, fatigue |
| 40 | 2021-01-23 | palpitations |
Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area...
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Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.
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| 40 | 2021-01-24 | chest discomfort, heart rate increased, loss of consciousness, blood pressure increased |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | lightheadedness |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.
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| 40 | 2021-01-24 | lightheadedness |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.
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| 40 | 2021-01-25 | heart rate abnormal |
BP 180/110, HR 140. Baseline is BP 110/70, HR55. Slowly returned to baseline but with dizziness an...
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BP 180/110, HR 140. Baseline is BP 110/70, HR55. Slowly returned to baseline but with dizziness and lightheaded symptoms for the remainder of the day.
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| 40 | 2021-01-25 | heart rate increased |
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi...
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Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-01-25 | chest pain |
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ...
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I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
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| 40 | 2021-01-25 | fast heart rate |
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; T...
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Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 40 | 2021-01-25 | chest pain |
Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneou...
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Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-01-25 | fast heart rate |
fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable n...
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fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.
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| 40 | 2021-01-26 | hypotension |
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP...
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After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
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| 40 | 2021-01-26 | fainting |
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync...
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Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
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| 40 | 2021-01-26 | fast heart rate |
Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, ...
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Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021
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| 40 | 2021-01-26 | heart rate increased |
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a co...
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Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.
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| 40 | 2021-01-26 | chest discomfort | Tightness in chest, chest congestion without cough , or fever. Need not seek medical attention . |
| 40 | 2021-01-26 | chest discomfort, chest pain |
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels li...
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body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.
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| 40 | 2021-01-26 | palpitations |
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr...
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heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
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| 40 | 2021-01-27 | palpitations |
Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpi...
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Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
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| 40 | 2021-01-27 | loss of consciousness |
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,...
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Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
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| 40 | 2021-01-27 | heart rate increased |
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with...
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Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
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| 40 | 2021-01-27 | hypotension |
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;...
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weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-28 | increased heart rate, blood pressure increased |
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira...
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Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
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| 40 | 2021-01-28 | heart rate increased |
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too...
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Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
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| 40 | 2021-01-28 | coughing up blood |
My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I ha...
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My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.
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| 40 | 2021-01-28 | loss of consciousness |
patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out an...
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patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out and had to go to the hospital; she was treated with IV fluids, meclizine, and ativan
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| 40 | 2021-01-30 | heart rate increased |
PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 1...
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PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 153), injection site pain PT took Tylenol at home, presented to ED r/t high heart rate
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| 40 | 2021-01-31 | heart rate increased | I had a rapid heart beat and a headache that wouldn't go away for two days! |
| 40 | 2021-01-31 | fast heart rate |
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. ...
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Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
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| 40 | 2021-01-31 | chest discomfort |
chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot...
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chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-02-01 | fainting |
Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 3...
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Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 30 minutes,,was just very tired rest of day
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| 40 | 2021-02-01 | palpitations, lightheadedness |
Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a c...
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Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.
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| 40 | 2021-02-01 | chest discomfort, chest pain |
after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the ...
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after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI
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| 40 | 2021-02-02 | palpitations |
Client stated she felt her "heart racing". Client continued to be coherent. 1:33 pm B/P 144/98 ...
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Client stated she felt her "heart racing". Client continued to be coherent. 1:33 pm B/P 144/98 pulse=103 Pulse Oximeter 98% 1:37 pm B/P 142/78 pulse=107 Pulse Oximeter 94% 1:42 pm B/P 110/88 pulse=087 Pulse Oximeter 94% 1:45 pm B/P 118/94 pulse=109 Pulse Oximeter 94% 1:47 pm B/P 120/90 pulse=107 Pulse Oximeter 94% Client stated she had a history of heart palpitations; also stated she had had a similar event after she received her flu shot. Client stated she felt fine. Was going to return to work. Encouraged to contact medical provider if symptoms returned.
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| 40 | 2021-02-02 | palpitations |
Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adver...
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Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adverse reaction. At 4:25pm patient started to fee palpations, braking out with redness on her chest and her left arm where the vaccine was administrated. Epinephrine 0.3 mg auto injector was given in her right thigh by the doctor. We then called 911 to transport her to the emergency room.
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| 40 | 2021-02-02 | inflammation of the heart muscle, chest pain, troponin increased |
The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG c...
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The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.
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| 40 | 2021-02-03 | chest pain |
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond...
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December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
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| 40 | 2021-02-03 | heart rate increased |
Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted ...
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Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-02-04 | fast heart rate |
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe...
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45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
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| 40 | 2021-02-04 | palpitations | Fast heart rate, sought treatment at the ER, dc paperwordkstated orthostatic hypotension |
| 40 | 2021-02-04 | lightheadedness, palpitations, pallor |
felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was...
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felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 40 | 2021-02-07 | heart rate increased, blood glucose increased |
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,...
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Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
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| 40 | 2021-02-07 | palpitations |
Strong palpitations for about 12 hours. Palpitations improved slightly be sitting/leaning forward. ...
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Strong palpitations for about 12 hours. Palpitations improved slightly be sitting/leaning forward. I am a physician and this made me concerned for pericarditis. However, I am also on fluconazole which can contribute to cardiac arrhythmias. The palpitations had resolved in the morning and so I did not seek diagnosis and treatment.
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| 40 | 2021-02-08 | blood pressure increased |
10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM...
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10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM: 150/98; RT. ARM: 152/100. has hypertension, has not been taking her BP meds for over 1 month.
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| 40 | 2021-02-08 | fast heart rate |
Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment w...
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Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment was given. Patient was observed and later discharged
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| 40 | 2021-02-08 | pallor, heart rate increased |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-09 | hypertension, heart rate increased, blood glucose increased |
5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heart...
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5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high
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| 40 | 2021-02-09 | lightheadedness |
Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spon...
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Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-02-09 | chest discomfort |
Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I though...
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Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.
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| 40 | 2021-02-09 | chest discomfort | Systemic: Other- chest tightness, flushing, and signs of panic |
| 40 | 2021-02-09 | palpitations | Systemic: Other- palpitation-Mild |
| 40 | 2021-02-09 | heart rate increased |
my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; fel...
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my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
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| 40 | 2021-02-09 | palpitations |
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t...
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uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
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| 40 | 2021-02-11 | blood pressure increased | Systemic: Other- cold finger tips, raised bloodpressure; lasted 1 day |
| 40 | 2021-02-14 | chest pain | Chest pain, SOB. |
| 40 | 2021-02-14 | fainting |
Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I ...
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Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I was given no warning that this could happen.
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| 40 | 2021-02-14 | hypertension | Red face, high blood pressure |
| 40 | 2021-02-14 | heart rate decreased |
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w...
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red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
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| 40 | 2021-02-15 | chest discomfort | ON 2/10/21, DEVELOPED BODY ACHES, CHILLS, CHEST TIGHTNESS, NAUSEA, HEADACHE, AND FEVER. |
| 40 | 2021-02-15 | heart rate increased, palpitations | Sudden palpitations 205 heart rate |
| 40 | 2021-02-16 | chest pain, chest discomfort |
Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in lef...
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Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable
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| 40 | 2021-02-16 | blood clot |
Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hou...
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Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period
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| 40 | 2021-02-16 | fast heart rate |
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea...
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Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
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| 40 | 2021-02-17 | heart rate increased |
approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and...
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approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow
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| 40 | 2021-02-17 | fainting |
tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for...
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tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-02-18 | palpitations |
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain...
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24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
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| 40 | 2021-02-21 | heart rate increased |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | loss of consciousness, fainting |
Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, ...
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Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.
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| 40 | 2021-02-21 | palpitations |
complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 1...
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complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.
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| 40 | 2021-02-22 | palpitations, chest discomfort |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-23 | vaginal haemorrhage |
Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches an...
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Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches and very regular cycle
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| 40 | 2021-02-23 | chest pain |
I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the...
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I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap
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| 40 | 2021-02-23 | pallor |
Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with...
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Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic
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| 40 | 2021-02-24 | chest discomfort, hypertension |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium
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| 40 | 2021-02-25 | fainting | Headache, fatigue, vomiting, fainting, muscle soreness, digestive issues. |
| 40 | 2021-02-26 | heart rate increased, palpitations |
During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was poundi...
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During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.
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| 40 | 2021-02-28 | heart rate increased |
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte...
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About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
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| 40 | 2021-02-28 | pallor, blood pressure increased |
Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throug...
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Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying
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| 40 | 2021-02-28 | vaginal haemorrhage |
I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated ...
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I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated due date was 08/24/2021. I began bleeding and cramping and having headaches approximately 10 days after my second dose. I sought medical attention and was told that my baby no longer had a heart beat and that growth (based on ultrasound) had stopped around the 9 week mark. I had medical assistance to physically miscarry the deceased fetus. I have one healthy living son (2 years, 4 months old) who was delivered without complications naturally.
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| 40 | 2021-02-28 | heart rate increased, hypertension |
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press...
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felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
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| 40 | 2021-02-28 | heart rate increased |
patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose ...
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patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.
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| 40 | 2021-02-28 | fainting |
patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local e...
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patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.
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| 40 | 2021-03-01 | chest pain, heart rate increased |
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,...
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Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
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| 40 | 2021-03-02 | heart rate increased |
Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade feve...
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Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm
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| 40 | 2021-03-02 | loss of consciousness |
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef...
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Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
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| 40 | 2021-03-03 | chest pain |
General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back o...
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General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
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| 40 | 2021-03-04 | pallor |
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi...
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After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
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| 40 | 2021-03-04 | fainting, pallor |
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a...
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At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
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| 40 | 2021-03-04 | hypertension |
Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pres...
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Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.
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| 40 | 2021-03-04 | chest discomfort |
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP ...
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shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
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| 40 | 2021-03-04 | fast heart rate |
supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b...
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supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b/m
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| 40 | 2021-03-05 | loss of consciousness |
8 minutes after the administration of the vaccine (while in the observation area) I started to feel ...
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8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
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| 40 | 2021-03-05 | heart rate decreased, hypotension |
during observation a few minutes after receiving immunization, patient developed dizziness, low bloo...
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during observation a few minutes after receiving immunization, patient developed dizziness, low blood pressure and heart rate (vasovagal response), improved within 5 minutes with leg elevation and drinking water
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| 40 | 2021-03-07 | hypertension |
High Blood Pressure (170/78) I do not have hypertension. Irregular vaginal bleeding. Starting bleedi...
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High Blood Pressure (170/78) I do not have hypertension. Irregular vaginal bleeding. Starting bleeding mid cycle for a day. This has never happened to me. I have a normal menstrual cycle.
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| 40 | 2021-03-07 | fainting |
Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp....
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Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.
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| 40 | 2021-03-07 | lightheadedness |
Near syncope (multiple events); vomiting (multiple events); chills; headache Onset approx. 12 hours ...
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Near syncope (multiple events); vomiting (multiple events); chills; headache Onset approx. 12 hours following vaccine. Rapid onset with little to no warning, lasting approx. 2-3 hours.
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| 40 | 2021-03-07 | lightheadedness |
Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrin...
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Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrine IM, sent to ED for eval
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| 40 | 2021-03-07 | chest pain, lightheadedness |
Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing a...
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Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.
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| 40 | 2021-03-07 | palpitations | Patient endorses palpitations since she received vaccine |
| 40 | 2021-03-07 | chest pain, palpitations |
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre...
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Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
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| 40 | 2021-03-07 | blood pressure increased, heart rate increased |
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak...
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Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
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| 40 | 2021-03-07 | chest pain |
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous...
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chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 40 | 2021-03-07 | chest discomfort | throat tightness, chest pressure, 0 diff. breathing. Evaluated by EMS-Cleared |
| 40 | 2021-03-08 | chest discomfort, fainting |
About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100. Fatigued, so...
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About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100. Fatigued, so went to bed and took ibuprofen. Continued to have significant body aches and rigors. While lying in bed, developed nausea. I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode. I returned to bed bed and still felt very lightheaded and laid down. I had another brief syncopal episode while lying down. I felt short of breath and had chest tightness when I woke up. This was around 11pm. I was evaluated in the ED, where I continued to have body aches and rigors. I developed fever to 101 and was given Advil and Tylenol as well as IVF. Symptoms finally resolved. Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal. Continued to feel significantly fatigued for an additional 48 hours.
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| 40 | 2021-03-08 | chest discomfort |
Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4...
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Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.
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| 40 | 2021-03-09 | hypotension | blurred vision, diaphoresis, hypotension, placed in trendelburg position |
| 40 | 2021-03-09 | heart rate increased |
flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphy...
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flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphylaxis
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| 40 | 2021-03-13 | heart rate increased, hypertension | FEELS LIKE BP IS HIGH, ELEVATED HR, WEAKNESSS. Evaluated by EMS- refusal to transport. |
| 40 | 2021-03-15 | blood pressure increased |
Progress Notes Expand AllCollapse All Patient: ...
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Progress Notes Expand AllCollapse All Patient: DOB: 4/11/1980 Date: 3/16/2021 MRN: Subjective Patient is a 40 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience generalized weakness, "need for a quick snack". She denied rash, shortness of breath, difficulty swallowing or syncope This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to red flag findings ALLERGY REVIEW OF SYSTEMS Previous Reactions: none Objective Vitals Vitals: 03/16/21 0944 BP: (!) 158/103 Pulse: (!) 102 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. Comments: Anxious on arrival to bay, "I think I just need a snack to feel better." HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious affect Clinically, post injection anxiety related event. Elevated BP on arrival, improved with rest and granola bar. Salient anxious affect, post injection histamine response, requiring warm blanket, prolonged rest Ambulated with assist, additional snacks provided and pt discharged after 45" stay Assessment/Plan Treatment included: snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
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| 40 | 2021-03-16 | heart rate increased, cardiac arrhythmia |
experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; ...
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experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.
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| 40 | 2021-03-17 | lightheadedness, palpitations |
Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable hea...
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Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not been diagnosed with Covid prior to vaccination. She was not pregnant. On 21Jan2021, the patient experienced increased heart palpitations and almost passed out immediately after second shot. No treatment was received for the events. Events resulted to doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. The patient was not tested for Covid post vaccination. Information on the batch/ lot number has been requested.
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| 40 | 2021-03-17 | blood pressure increased |
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid...
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Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
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| 40 | 2021-03-18 | palpitations | Heart racing |
| 40 | 2021-03-18 | chest discomfort |
I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, t...
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I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.
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| 40 | 2021-03-18 | heart rate increased |
Throat irritation like it was closing. HR elevated to 120-130. Clear airway with no wheezing, no st...
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Throat irritation like it was closing. HR elevated to 120-130. Clear airway with no wheezing, no stridor. Gave 25 mg Benadryl IM but then patient started coughing. Again checked airway, clear with normal lung sounds however with elevated heart rate, persistent coughing, called 911.
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| 40 | 2021-03-18 | hypertension, heart rate increased, anaemia, fast heart rate, chest discomfort |
heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia...
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heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.
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| 40 | 2021-03-18 | heart rate increased |
severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat;...
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severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received. Information on about lot/batch number has been requested.
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| 40 | 2021-03-19 | fast heart rate, palpitations |
I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a car...
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I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.
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| 40 | 2021-03-19 | heart rate increased, blood pressure increased |
Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness la...
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Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia
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| 40 | 2021-03-20 | blood pressure increased, palpitations |
40 yo F with palpitations about 10-15 mins after getting the vaccine. HR was 104, came down to 88, w...
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40 yo F with palpitations about 10-15 mins after getting the vaccine. HR was 104, came down to 88, without intervention. BP was elevated 160s/100s. Pt otherwise asymptomatic. Advised to continue monitoring her blood pressure and follow-up with her doctor. Pt observed for 30 minutes then discharged home.
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| 40 | 2021-03-20 | hypertension, heart rate increased, heart rate abnormal, blood pressure increased |
About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing co...
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About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.
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| 40 | 2021-03-20 | chest pain | Burning chest pain, cough, sore throat, sweats, fever, shortness of breath, sore arm, achey |
| 40 | 2021-03-20 | palpitations |
c/o lightheaded ness & heart palpitations for min. post injection. h/o increased BP; no meds take...
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c/o lightheaded ness & heart palpitations for min. post injection. h/o increased BP; no meds taken this AM. Symptom quickly improved with mask removal & fresh air. Reported most likely R/T anxiety. On recheck - reported symptoms resolved. BP 130/86; HR 86; drove off lot independently.
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| 40 | 2021-03-22 | nosebleed |
10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (...
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10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)
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| 40 | 2021-03-22 | heart rate increased |
On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nause...
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On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.
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| 40 | 2021-03-22 | chest discomfort |
Pfizer bio N Tech covid 19 Started with a slight cough then my throat felt like I couldn't swallow r...
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Pfizer bio N Tech covid 19 Started with a slight cough then my throat felt like I couldn't swallow right. Then went to a persistent cough and got hard to swallow chest was tight. Went to the er and was given an epi in and 5 other meds through the iv. Also given a breathing treatment. They diagnosed me with an allergic reaction.
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| 40 | 2021-03-22 | hypertension, fast heart rate | Within 10 minutes, I experienced tachycardia, hypertension, Sweating and shaking. |
| 40 | 2021-03-23 | chest discomfort |
Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of se...
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Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO. Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.
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| 40 | 2021-03-24 | palpitations |
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo...
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03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
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| 40 | 2021-03-24 | nosebleed |
Bloody nose in my right nostril. I rarely get bloody noses and am unsure if it?s related to the vacc...
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Bloody nose in my right nostril. I rarely get bloody noses and am unsure if it?s related to the vaccine. It took approximately 10 minutes of heavy bleeding to cease.
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| 40 | 2021-03-24 | lightheadedness |
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self...
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Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
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| 40 | 2021-03-24 | pallor |
PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREAT...
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PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREATH. AFTERWARDS HAD HER SIT IN WAITING ROOM FOR THE 15 MINUTES. AFTER A COUPLE OF MINUTES SHE APPROACHED COUNTER AND SAID SHE WAS NOT FEELING WELL, I HAD HER SIT BACK DOWN, HAD MY TECHNICIAN CALL 911, AND RETRIEVED THE EPI-PEN. AS I WAS APPROACHING HER SHE SLUMPED OVER. I TRIED TALKING TO HER, THERE WAS NO RESPONSE AND WAS TURNING PALE. I ADMINISTERED THE EPI-PEN AND WITHIN A FEW SECONDS SHE WAS RESPONDING. THERE WAS A NURSE IN THE STORE WHO BEGAN MONITORING THE PATIENTS HEART RATE AND BLOOD PRESSURE. THE PATIENT WAS TALKING TO US BUT STILL NOT FEELING WELL. A COUPLE MINUTES LATER THE EMS ARRIVED AND TOOK HER TO THE HOSPITAL
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| 40 | 2021-03-24 | fainting |
Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a...
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Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a syncopal episode where pt was seen with flexed arms and bladder incontinence. Pt was AOx4 after regaining consciousness with SBP in the 80s, diaphoresis, and nausea. Pt did report history of syncopal events associated with needles and SBP around 90s. Pt was monitored and later released by medical staff and EMS after symptoms resolved. PT was instructed to follow up with PCM regarding possible concerns for seizures and hypotension.
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| 40 | 2021-03-24 | excessive bleeding | Severe bleeding resolved within 7 days |
| 40 | 2021-03-25 | hypertension | B/P high, redness to face, Left arm numbness |
| 40 | 2021-03-25 | palpitations, vaginal haemorrhage |
My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. Ab...
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My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.
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| 40 | 2021-03-25 | chest discomfort |
Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine,...
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Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram
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| 40 | 2021-03-26 | heart rate increased, palpitations |
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati...
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After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
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| 40 | 2021-03-26 | chest pain | lightheaded, dizzy, chest pain |
| 40 | 2021-03-27 | fibrin d dimer increased, fast heart rate, fainting |
Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swellin...
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Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.
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| 40 | 2021-03-27 | hypertension, heart rate increased |
lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lip...
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lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.
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| 40 | 2021-03-30 | chest pain |
Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to ...
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Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.
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| 40 | 2021-03-30 | pulse abnormal, chest discomfort, blood pressure decreased |
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the...
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Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
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| 40 | 2021-03-30 | heart rate increased |
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; m...
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sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
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| 40 | 2021-04-06 | chest pain |
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ...
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dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
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| 40 | 2021-04-08 | pulmonary embolism | pulmonary embolism, symptomatic |
| 40 | 2021-04-16 | nosebleed, platelet count decreased |
March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breast...
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March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breastfeeding. Delivery date 12/28/2020 April 10 noticed petechia and abnormal bruising but with high energy April 13 - second COVID shot. April 13 - nose bleed with continued petechia and abnormal bruising. No other symptoms
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| 40 | 2021-04-17 | fainting |
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d...
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Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
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| 40 | 2021-04-20 | fast heart rate, low blood oxigenation, palpitations |
At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as order...
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At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
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| 40 | 2021-04-21 | fast heart rate |
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,...
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throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
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| 40 | 2021-04-24 | loss of consciousness |
lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries wi...
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lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
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| 40 | 2021-04-26 | transient ischaemic attack |
Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred v...
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Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 40 | 2021-04-27 | chest discomfort |
Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands...
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Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands and feet. Left large bruises. Rash diminished to small spots with prednisone/benadryl. Have photos.
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| 40 | 2021-04-30 | heart flutter |
Intermittent racing fluttering heart; This is a spontaneous report from a contactable consumer (pati...
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Intermittent racing fluttering heart; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in the right arm on 13Mar2021 at 18:30 (at the age of 40-year-old) and the second dose was administered in the left arm on 02Apr2021 at 13:00 (at the age of 40-year-old); both dose were administered via an unspecified route at a pharmacy or drug store facility as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not COVID tested post vaccination. Medical history included known allergies to Penicillin. The patient was on unspecified concomitant medications. On 20Mar2021, the patient experienced intermittent racing fluttering heart. It started the week after the first shot and intensified the week after he second. No treatment was given for the event. The patient had not yet recovered from the event. Information on the lot/ batch number has been requested.
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| 40 | 2021-05-03 | vaginal haemorrhage, blood clot |
more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pa...
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more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pain; more than usual vaginal bleeding; more than usual vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Facility type Vaccine: Other. Medical history included known allergies: Sulfa and Folate deficiency. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) on 15Mar2021 10:30 AM in left arm for covid-19 immunisation and experienced vaginal bleeding/blood clots at mid-cycle on 15Mar2021 08:00 PM. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced more than usual vaginal bleeding/with very dark blood with clots, menstrual cramps, sharp pelvic pain, all on Apr2021 with outcome of not recovered. Clinical course: After the first dose, the patient had vaginal bleeding/blood clots at mid-cycle. The same day after the 2nd dose, she started feeling menstrual cramps and sharp pelvic pain. After taking paracetamol (TYLENOL) and feeling a bit of relief, she stood up and started having more than usual vaginal bleeding at the level that it reached the floor as if it was a hemorrhage with very dark blood with clots. This lasted for 1 minute. This lasted for 5 days and 7 days later, she started bleeding again with dark blood clots for a period of 3 days. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for events more than usual vaginal bleeding/with very dark blood with clots.
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| 40 | 2021-05-04 | blood clot, vaginal haemorrhage |
vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleedi...
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vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6206, via an unspecified route of administration, administered in left arm on 15Mar2021 10:30 as single dose for Covid-19 immunisation. Medical history included folate deficiency and allergies to sulfa. There were no concomitant medications. After the first dose on 15Mar2021, the patient had vaginal bleeding/blood clots at mid-cycle. No treatment information was provided. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association reported events causal relationship with BNT162B2 cannot be excluded. Case to be re-assessed upon receipt of new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-05-05 | heart rate increased |
Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy...
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Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.
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| 40 | 2021-05-07 | ischemic chest pain, hypotension |
acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a s...
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acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a spontaneous report from a contactable consumer (the patient). This 40-year-old (non-pregnant) female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had tested negative for COVID-19 with the Nasal Swab Real-time PCR tests on 17Oct2020 and again on 02Feb2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did have an allergy to eggs and having no other medical history. The patient stated that she is completely healthy. The patient's concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination. On 02Apr2021 at 10:00 AM, the patient experienced strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever. No treatment was received for the adverse events. The patient had a low blood pressure measured 80/50 mmHg on 02Apr2021. The clinical outcomes of the strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever were resolved in Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 40 | 2021-05-10 | pulmonary embolism |
PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL...
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PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION
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| 40 | 2021-05-11 | hypertension, fast heart rate, heart rate increased |
Her blood pressure spiked, and was very high the night of the day she got her first COVID-19 Vaccine...
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Her blood pressure spiked, and was very high the night of the day she got her first COVID-19 Vaccine; she had a high heart rate of 148; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 24Apr2021 at 15:10 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included pre-eclampsia on 13May2010 (first diagnosed with pre-eclampsia while in labor with her son on 13May2010), blood pressure high from 13May2010 and ongoing, irregular heartbeat from an unspecified date and unspecified if ongoing (she had an irregular heart beat all her life, for at least 20 years. She said her heart skips a beat), leaky heart valve from an unspecified date and unspecified if ongoing (diagnosed approximately 7 years ago) and heart rate high (her heart rate was typically higher than most peoples). The patient had no history of previous immunizations with the COVID-19 vaccine. Concomitant medications included atenolol (TENORMIN; tablet; strength: 25mg) taken for blood pressure from an unspecified date and ongoing at 25mg, unspecified frequency. Other products were also reported as "no". The patient did not receive additional vaccines on the same date or within 4 weeks of the COVID-19 vaccine. On 24Apr2021 at 18:30 the patient experienced her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine and she had a high heart rate of 148. The patient called to inquire whether an increased blood pressure was a side effect of the first COVID-19 vaccine dose. She reported that her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine (on Saturday, 24Apr2021). She said her (highest) blood pressure readings were 184/170 and 218/130. She said she had a high heart rate of 148, as well. On Saturday, 24Apr2021, between 6:30PM-7:00PM, her smart watch alerted her that her heart rate had increased to 114, so she decided to check her blood pressure. She said she checked her blood pressure at home first with a blood pressure machine that she already had. She said when she saw her high blood pressure readings, she was hopeful that the blood pressure machine was wrong. She said she went out and spent $80 on a brand-new blood pressure machine to recheck her blood pressure, and her blood pressure readings were still high. Her husband and daughter got their COVID-19 vaccines at the same time she did. She said her husband and daughter's blood pressure readings were fine with both blood pressure machines she had used. She had already taken a blood pressure pill that morning (clarified as Atenolol 25mg), so she drank a bunch of water, and hoped for the best. The urgent care was already closed, and she did not want to go to the hospital because of the COVID-19 virus. She said she took 1 Atenolol 25mg tablet in the morning (on 24Apr2021). Her blood pressure was still higher than normal, providing 134/86 as her latest blood pressure reading this morning (27Apr2021). She said her heart rate was 75 this morning. She said her heart rate was typically higher than most peoples. She also reported that she was first diagnosed with pre-eclampsia while in labor with her son on 13May2010. She said from that point on she was told she would have high blood pressure. She stated her high blood pressure was treated. She said her blood pressure normally ran within a few numbers above or below 120/80. The adverse events did not require a visit to the emergency room or to the physician office. The clinical outcomes of the events her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine and she had a high heart rate of 148 were both recovering/resolving. No Follow-up attempts are needed. No further information is expected.
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| 41 | 2020-12-31 | fast heart rate |
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe...
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Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
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| 41 | 2021-01-01 | palpitations, fast heart rate |
Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water...
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Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.
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| 41 | 2021-01-01 | fast heart rate, palpitations, chest discomfort |
Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five da...
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Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.
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| 41 | 2021-01-02 | chest pain |
Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, ba...
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Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative
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| 41 | 2021-01-04 | palpitations, hypertension, fast heart rate |
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien...
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15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
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| 41 | 2021-01-04 | chest discomfort, hypertension |
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ...
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20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
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| 41 | 2021-01-04 | chest discomfort |
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and...
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On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
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| 41 | 2021-01-06 | blood pressure increased, heart rate increased |
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra...
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Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
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| 41 | 2021-01-06 | fainting | Light headedness, skin flushing, syncope |
| 41 | 2021-01-06 | palpitations |
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ...
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tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
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| 41 | 2021-01-07 | fainting |
About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling li...
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About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.
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| 41 | 2021-01-07 | fast heart rate, atrial fibrillation |
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur...
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Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
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| 41 | 2021-01-07 | blood pressure increased, hypertension, blood glucose increased |
NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes late...
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NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.
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| 41 | 2021-01-07 | blood pressure increased |
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something...
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Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
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| 41 | 2021-01-07 | blood pressure increased, heart rate increased |
Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and ...
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Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.
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| 41 | 2021-01-07 | palpitations, chest discomfort, fast heart rate |
Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontane...
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Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.
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| 41 | 2021-01-07 | chest discomfort | chest tightness arm pain nausea diarrhea body aches fatigue lost work two days |
| 41 | 2021-01-07 | fast heart rate |
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest...
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chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
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| 41 | 2021-01-08 | chest pain |
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte...
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2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
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| 41 | 2021-01-08 | heart rate increased, fast heart rate |
About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lig...
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About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.
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| 41 | 2021-01-08 | heart rate increased, lightheadedness | Fever, chills, weakness, myalgias, near syncope, increased heart rate. |
| 41 | 2021-01-08 | hypertension | NauseaVomiting, HYPERtension & HYPERglycemia |
| 41 | 2021-01-08 | chest pain, palpitations, cardiac arrhythmia |
Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flu...
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Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
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| 41 | 2021-01-08 | heart rate increased |
Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no h...
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Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.
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| 41 | 2021-01-09 | chest discomfort | 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches |
| 41 | 2021-01-09 | heart rate increased, blood pressure increased |
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ...
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I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
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| 41 | 2021-01-09 | chest discomfort |
Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days aft...
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Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine
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| 41 | 2021-01-10 | fast heart rate |
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo...
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Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
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| 41 | 2021-01-10 | hypertension |
On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/2...
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On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.
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| 41 | 2021-01-10 | palpitations | c/o palpitations, dizziness |
| 41 | 2021-01-11 | chest discomfort |
2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little wo...
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2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.
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| 41 | 2021-01-11 | blood glucose increased | Blood sugar > 300 consistently started observing day after second dose |
| 41 | 2021-01-11 | chest pain |
Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but...
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Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.
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| 41 | 2021-01-11 | hypertension |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-11 | heart rate increased |
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h...
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Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
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| 41 | 2021-01-11 | palpitations |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | fast heart rate |
Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her th...
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Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.
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| 41 | 2021-01-11 | palpitations, fast heart rate |
Patient reported to observation area for monitoring post-Injection. Â No prior history of adverse ...
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Patient reported to observation area for monitoring post-Injection.  No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.  She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.  Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling  Patient placed in supine position on stretcher, received water hard candy.  Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.  After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
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| 41 | 2021-01-12 | nosebleed |
Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody ...
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Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody nose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 04Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient had numbness at the site of the injection which was the left side (arm), and only on the left side; and had bloody nose. The patient had received treatment for the reported adverse event. The outcome of the events, 'numbness at the site of the injection' and 'bloody nose', was unknown.
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| 41 | 2021-01-12 | chest pain |
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ...
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The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
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| 41 | 2021-01-13 | chest pain |
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days....
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10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
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| 41 | 2021-01-13 | blood pressure increased |
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm...
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1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
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| 41 | 2021-01-13 | blood pressure increased |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | palpitations, blood pressure increased |
Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensatio...
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Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.
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| 41 | 2021-01-13 | blood pressure increased, heart rate increased |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | lightheadedness |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | chest discomfort |
Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharm...
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Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.
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| 41 | 2021-01-13 | fast heart rate, hypertension, chest discomfort |
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea...
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severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-01-13 | fast heart rate, hypertension |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-14 | chest discomfort |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | heart rate increased |
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext...
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Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
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| 41 | 2021-01-14 | hypertension, blood pressure increased |
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join...
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Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
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| 41 | 2021-01-14 | palpitations |
I started developing walloping palpitations around 3 hours after vaccine was given. They have conti...
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I started developing walloping palpitations around 3 hours after vaccine was given. They have continued now for 18 hours post vaccination and I have never had these before in my life. I have numerous per hour but can be symptom free from time to time. No significant cardiac history before.
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| 41 | 2021-01-14 | heart rate increased | Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety |
| 41 | 2021-01-14 | palpitations |
became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED...
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became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home
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| 41 | 2021-01-14 | heart rate increased | hot flash and rapid heartrate |
| 41 | 2021-01-14 | heart rate increased | lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate |
| 41 | 2021-01-15 | blood pressure increased, palpitations |
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFi...
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Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
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| 41 | 2021-01-16 | palpitations |
AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine...
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AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection
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| 41 | 2021-01-16 | chest discomfort |
Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tight...
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Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.
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| 41 | 2021-01-16 | chest discomfort |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-17 | heart rate increased |
10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more th...
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10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.
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| 41 | 2021-01-17 | palpitations, chest pain, increased heart rate, oxygen saturation decreased |
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch...
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COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
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| 41 | 2021-01-17 | lightheadedness |
I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I deve...
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I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.
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| 41 | 2021-01-17 | heart rate increased, blood pressure increased |
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ...
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Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
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| 41 | 2021-01-17 | chest discomfort, fast heart rate |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | chest discomfort |
22 hours after the second dose started to have an allergic reaction, hives all over back and chest a...
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22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
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| 41 | 2021-01-18 | blood pressure fluctuation |
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/...
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5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
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| 41 | 2021-01-18 | fast heart rate |
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Sym...
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Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
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| 41 | 2021-01-18 | palpitations |
Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed ...
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Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.
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| 41 | 2021-01-18 | chest discomfort, fast heart rate |
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f...
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Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
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| 41 | 2021-01-18 | chest discomfort, palpitations | palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week |
| 41 | 2021-01-19 | chest discomfort |
Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the s...
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Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.
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| 41 | 2021-01-19 | chest pain, platelet count decreased, low blood platelet count |
Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain th...
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Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.
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| 41 | 2021-01-19 | heart rate increased, pallor, palpitations, blood pressure increased |
The patient self-reported this adverse reaction through the hospital electronic reporting system. I...
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The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
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| 41 | 2021-01-20 | chest discomfort | Pressure in chest(like something was sitting on my chest)lasted 4-5days post vaccine |
| 41 | 2021-01-20 | fainting, fast heart rate |
Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feel...
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Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out
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| 41 | 2021-01-20 | palpitations |
itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears...
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itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
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| 41 | 2021-01-20 | heart rate increased |
states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the va...
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states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued
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| 41 | 2021-01-21 | fainting | Congestion, out of body experience (like a fog where you cannot think), headache, syncope |
| 41 | 2021-01-21 | hypertension, heart rate increased, fast heart rate |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-22 | chest discomfort, chest pain |
About one hour post injections I started developing chest pain and pressure. It worsened throughout ...
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About one hour post injections I started developing chest pain and pressure. It worsened throughout the day and because I was worried about a cardiac event, I went to the emergency room.
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| 41 | 2021-01-22 | chest pain | Chest pain, lethargy, burning airway |
| 41 | 2021-01-22 | blood pressure increased |
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-li...
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For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.
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| 41 | 2021-01-23 | heart rate increased |
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe...
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Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
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| 41 | 2021-01-24 | heart rate increased |
body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizz...
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body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm
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| 41 | 2021-01-25 | chest discomfort | Itchy throat, sudden warmth, see spots, chest tightness. |
| 41 | 2021-01-25 | palpitations |
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in m...
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My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
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| 41 | 2021-01-25 | palpitations |
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the to...
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heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-01-26 | fainting |
I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days...
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I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .
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| 41 | 2021-01-26 | palpitations |
Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitati...
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Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better
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| 41 | 2021-01-26 | fainting |
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o...
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seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-26 | hypotension, fast heart rate |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-27 | heart rate increased |
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s....
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40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
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| 41 | 2021-01-27 | heart rate abnormal, chest pain |
All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest p...
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All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite
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| 41 | 2021-01-27 | heart rate abnormal, chest pain |
All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, sever...
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All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.
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| 41 | 2021-01-27 | chest pain |
Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within norm...
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Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.
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| 41 | 2021-01-27 | low platelet count, platelet count decreased | neutropenia & thrombocytopenia |
| 41 | 2021-01-27 | heart rate increased |
rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous re...
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rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.
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| 41 | 2021-01-28 | hypertension |
1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states sh...
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1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
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| 41 | 2021-01-28 | heart rate increased |
This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her ...
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This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.
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| 41 | 2021-01-29 | blood pressure increased |
Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all ...
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Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased
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| 41 | 2021-01-30 | chest discomfort |
At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute ma...
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At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone
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| 41 | 2021-01-31 | heart rate irregular, chest pain | Chest pain...irregular heart rate...headache and body aches prior to the ER visit |
| 41 | 2021-01-31 | chest pain |
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area appro...
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red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.
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| 41 | 2021-02-01 | palpitations |
1/25 @ 3:30 Laid down and had a sudden racing heart rate. Maxed in the 150s, staying around 135 for ...
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1/25 @ 3:30 Laid down and had a sudden racing heart rate. Maxed in the 150s, staying around 135 for a prolonged period of time. No activity during this time. Lasted 40-45 minutes. Not sure if related to vaccine, but no other changes in routine/diet/medications.
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| 41 | 2021-02-01 | chest pain |
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani...
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Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
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| 41 | 2021-02-01 | lightheadedness | Vasovagal |
| 41 | 2021-02-02 | chest discomfort | Numbness and tingling in fingers and hands, shortness of breath, tightness in chest. |
| 41 | 2021-02-03 | loss of consciousness |
Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of a...
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Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.
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| 41 | 2021-02-03 | chest pain |
Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off ch...
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Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain. Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses
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| 41 | 2021-02-04 | blood pressure increased |
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was a...
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I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
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| 41 | 2021-02-04 | blood pressure increased, fast heart rate | Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe |
| 41 | 2021-02-05 | fast heart rate |
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachyca...
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Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
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| 41 | 2021-02-06 | fast heart rate |
Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, head...
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Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.
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| 41 | 2021-02-07 | palpitations, chest pain |
Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radi...
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Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 41 | 2021-02-08 | loss of consciousness |
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a...
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I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
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| 41 | 2021-02-08 | blood pressure increased |
Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer ...
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Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer brand). She complained of left sided facial numbness with no facial droop or slurred speech present at the time. Her vitals were taken, she was monitored and seen by a PA. She was given an education handout on allergic reactions to medications and scheduled to follow up with her primary care physician regarding her elevated blood pressure (182/100). Patient did not report prior history of hypertension. She was discharged and able to ambulate our of the ED and drive home. Coure of care approximately 1 hour.
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| 41 | 2021-02-09 | heart rate increased |
Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable ...
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Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
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| 41 | 2021-02-09 | heart rate increased, chest discomfort |
Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other...
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Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.
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| 41 | 2021-02-09 | heart rate increased |
heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable fe...
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heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.
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| 41 | 2021-02-10 | fainting, loss of consciousness |
Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old...
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Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-11 | palpitations, chest pain |
1/29 headache 1/30 headache body aches fatigue 1/31 headache body aches fatigue and low grade fever...
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1/29 headache 1/30 headache body aches fatigue 1/31 headache body aches fatigue and low grade fever 2/1 10 am chest pain heart palpitations headache and fatigue continued as well so I went to ER for cardiac work up all negative 2/2-2/5 symptoms the same with new onset of back pain...went to cardiologist he felt heart is fine but ordered echo and stress test for today 2/12 my symptoms improved not resolved since taking flexeril on 2/8. Today I still have the same headache chest pain back pain and palpitations. All of my tests have been normal so far this must be vaccine related and I?d like to speak with someone regarding this matter.
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| 41 | 2021-02-15 | chest discomfort, palpitations |
Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine ...
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Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.
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| 41 | 2021-02-16 | chest discomfort |
Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vita...
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Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
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| 41 | 2021-02-16 | chest discomfort |
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ...
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Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-02-16 | blood clot, deep vein blood clot |
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war...
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Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.
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| 41 | 2021-02-21 | fast heart rate |
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ...
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Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
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| 41 | 2021-02-21 | fast heart rate | Flushing, tachycardia, lip tingling |
| 41 | 2021-02-21 | palpitations | Racing heart for up to 8 hours over 152 pulse started 30 min after injection |
| 41 | 2021-02-21 | deep vein blood clot |
deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following inj...
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deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours
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| 41 | 2021-02-22 | loss of consciousness, pulse abnormal, pallor |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-22 | fainting | Vomiting fainting fever |
| 41 | 2021-02-24 | lightheadedness | COVID-19 Vaccine |
| 41 | 2021-02-25 | heart rate increased |
12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphores...
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12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphoresis
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| 41 | 2021-02-25 | palpitations | Palpitations, swollen lymph nodes under my left armpit and general malaise the day after the vaccine |
| 41 | 2021-02-25 | heart rate increased, fast heart rate |
Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, ...
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Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.
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| 41 | 2021-02-26 | heart rate increased | Significant lightheadedness, multiple spikes in heart rate |
| 41 | 2021-02-26 | fainting |
patient that fainted today. She reported on her screening questionnaire of passing out after receiv...
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patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.
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| 41 | 2021-03-01 | chest discomfort, chest pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | palpitations, chest pain |
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o...
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Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
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| 41 | 2021-03-02 | heart rate increased |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-02 | heart rate increased |
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flush...
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heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
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| 41 | 2021-03-03 | fainting |
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prio...
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After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
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| 41 | 2021-03-03 | chest pain |
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat...
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Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
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| 41 | 2021-03-03 | heart rate increased |
sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/...
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sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/resting. Over the course of the last 5 weeks it has lessened in severity
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| 41 | 2021-03-04 | palpitations |
About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nau...
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About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
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| 41 | 2021-03-07 | body temperature decreased, heart rate increased, pallor |
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea...
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Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 41 | 2021-03-07 | fast heart rate, chest pain |
o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient st...
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o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.
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| 41 | 2021-03-07 | chest pain, palpitations | weakness, nausea, vomiting, chest pain, cold sweats, heart palpitations |
| 41 | 2021-03-08 | chest discomfort, chest pain | Heaviness in chest, at times, sharp pains with deep breaths. Has lasted >24hrs |
| 41 | 2021-03-09 | coughing up blood |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-09 | hypotension | Low B/P |
| 41 | 2021-03-10 | palpitations |
Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8...
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Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days
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| 41 | 2021-03-11 | fainting |
Other than the normal symptoms of chills, body aches, feeling run down....the day after I had the se...
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Other than the normal symptoms of chills, body aches, feeling run down....the day after I had the second dose, I experienced a fainting episode and collapsed on the floor.
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| 41 | 2021-03-11 | palpitations |
Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a min...
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Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute. I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it
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| 41 | 2021-03-12 | heart rate irregular, hypertension, palpitations |
2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then ...
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2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.
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| 41 | 2021-03-12 | blood pressure decreased |
Patient complained of nausea and lightheadedness about 15 minutes after receiving the vaccine. She ...
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Patient complained of nausea and lightheadedness about 15 minutes after receiving the vaccine. She denied itching, hives, swelling of tongue or throat. Did not feel faint. Approximately 30-40 minutes later she had improvement of nausea and lightheadedness but felt some swelling on left side of throat. Physical exam still WNL. She declined paramedics. She wanted to leave and was felt to be stable. Did not become syncopal on standing. She is "7 belted mixed martial artist." Planned to return home and possibly take Benadryl. Left at approximately 3:50pm
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| 41 | 2021-03-12 | heart rate increased, blood pressure increased, chest pain |
Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It w...
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Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It was localized and did not radiate. It was not made worse by standing, sitting, laying, moving, eating, drinking. I was not short of breathe nor did breathing hurt. The pain was mild - a 2 to maybe a 3. Enough to know it was there but it did not limit me in any way. It has continued through the present. Saturday (3-13-2021) I started to notice a very rapid heart rate, from just walking across my house. I went down the basement stairs and walked up and I felt my heart was racing and pounding (this is something I do multiple times a day with ease). I have an oxometer and my heart was very high. I tried resting (by sitting) and my heart rate didn?t drop below the high 80s. I walked through a room and up a flight of stairs and down (in my home) and my heart rate peaked at 154 (wearing oxometer). My BP was also high for me 148/94. I called my primary care physicians office, spoke with a nurse that recommended I go to the emergency room. Tests were normal and I was released. The burning sensation remains. Since returning home heart rate gets high very easily and I can feel it pounding when I walk, though fortunately it hasn?t gone over the mid 130s. My blood pressure when checked at home was still high for me but quite a bit lower than when I first checked it at home. To be honest, I?m far from a pro at taking my BP so I?m not sure of the accuracy of either measurement.
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| 41 | 2021-03-15 | skin turning blue, loss of consciousness, pallor |
Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was...
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Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was told to breath deeply and she quickly started feeling "a little better" so she was helped to a chair with arm rests in the room. She said she had an orange in her bag, so she started eating her orange. Just a minute later she said she was going to pass out, so the pharmacist caught her. He held her up in the chair and tried to revive her for a few moments but noticed that the blood was draining from her face and her lips were turning blue so yelled for one of his technicians to call 911 and the other to grab an epi pen. He then lowered her to the floor in case he needed to begin to resuscitate while the technician brought him the epipen. While lowering her she urinated on herself. As the pharmacist went to check her vitals before administering the epipen and beginning cpr if necessary the patient suddenly gasped once and her eyes opened widely, but not continue to breath. Upon inspection in her mouth there was a piece of orange near the bottom of the throat. The pharmacist asked if she was choking and she did not response at all, but did not start visibly breathing either. So the pharmacist swiped the piece of orange out quickly, in case it was either previously lodged or patient would have to be resuscitated. She did not seem to enjoy this and this seemed to wake her up and she quietly gasped not choking. She started to quickly improve and admitted that she was feeling better, and had passed out before after getting blood drawn but never after a shot so didn't mention this. While this was happening a police office was going through the drive through so the technician called him in for assistance and he arrived around this time. He asked her a few questions like "what's her name, who's president, how many quarters are in a dollar" which she was able to answer. She said she was mostly embarrassed and was feeling much better. She sat up in the chair again about the time the emts came in. The checked her out, but she didn't want to go to the Emergency Room. She was driven home by her father. I called her later around 6 pm that night and she said she was feeling totally fine and I advised her to please call her PCP and discuss this incident with him or her.
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| 41 | 2021-03-16 | loss of consciousness |
I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. ...
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I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. I went home to pickup my daughter and at 6pm was back on the road driving and started to feel tired. I stopped at the light at foster and had just called my parents to tell them i had gotten the shot. I mentioned I was starting to feel tired and as I said it started to feel more tired. My mom responded maybe you should pull over and that was the last thing i remember as I fainted/blacked out immediately after. When I awoke my daughter (in the back seat along with my dog) explained that I had accelerated and hit the back of another car and then drove around that car, ending with both cars facing the direction of travel with my car in front of the car i had rear-ended. I was completely disoriented and had not recollection of hitting the gas or break much less driving. I was told two times that the driver in the other car was fine and was told when asked a third time that he did have some pain possibly and went in the ambulance to get checked out. I felt disoriented and jittery last night, took 2 Tylenol before bed and have felt fine today beyond feeling confused and horrible about what happen. My husband picked me up form the site and took me to my parents a few blocks north of the accident.
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| 41 | 2021-03-16 | heart rate increased, chest discomfort |
Resting heart rate in the 140s, normally in the 80s with heavy pressure on chest started 1 day after...
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Resting heart rate in the 140s, normally in the 80s with heavy pressure on chest started 1 day after shot and lasted for 2 days followed by asthma symptoms.
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| 41 | 2021-03-16 | palpitations | Sore arm, tiredness, foggy, fever, nausea, racing heart, pulpultations, diarrhea |
| 41 | 2021-03-17 | heart rate increased |
- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness...
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- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness and disequilibrium that were accompanied with mild nausea. The numbness in teeth went away after approximately 5 min. The waves of disequilibrium continued for 24hrs, and now feel more like a pressure headache. During these ?waves? I also had increased heart rate. - an hour after the shot, my left arm felt numb down to the fingers. Then the right arm and upper back. This subsided after an hour.
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| 41 | 2021-03-17 | palpitations, fainting |
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough;...
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sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 41 | 2021-03-19 | heart rate increased |
3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate, reported feeling flush, and was visibly shaking. Assessment : Time of assessment- 1845. Alert and oriented. Actions taken: Vitals sign taken at 1845 BP 139/84, P 74, T-98.2,R 16, O2- `100%, JUICE OFFERED AND ACCEPTED, RECHECK AT 1858, BP-156/75, P-116, DRINKING JUICE, AT 1918 BP- 131/82, P- 105, VS AT 1933 BP-113/59, P- 98, AT 1951- BP- 114/80, P-95, PATIENT FEELING BETTER AND LEFT WITH FAMILY. Medications administered: No medication administered. Disposition: PATIENT GIVEN INFORMATION OF ALLERGIC REACTION, AND ADVISED TO FOLLOW UP WITH PCP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 6:36 PM 0.3 mL 12/11/2020 Intramuscular
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| 41 | 2021-03-20 | palpitations |
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face...
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Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
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| 41 | 2021-03-21 | palpitations |
Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injec...
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Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injection.
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| 41 | 2021-03-21 | palpitations |
Pt received first dose of the Pfizer covid19 vaccine at 1014. Immediately after pt stated feeling a...
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Pt received first dose of the Pfizer covid19 vaccine at 1014. Immediately after pt stated feeling anxious, dizzy and like her heart was pounding. Pt was monitored, provided water and was released at 1140 after symptoms went away.
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| 41 | 2021-03-22 | fast heart rate, palpitations |
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ...
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About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
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| 41 | 2021-03-22 | heart rate increased |
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec...
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Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
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| 41 | 2021-03-23 | low blood platelet count |
Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable co...
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Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on an unspecified date (at age of 41 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. There was no COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications were not reported. The patient developed ITP (Idiopathic Thrombocytopenia Pura) on 23Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received dexamethasone. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-03-23 | palpitations, fast heart rate |
Tachycardia Patient states that she felt like her heart was racing s/p the vaccine administration....
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Tachycardia Patient states that she felt like her heart was racing s/p the vaccine administration. Patient is alert, oriented x3, NAD. Vitals: 136/85, HR 97, oxygen sat 97%. Lungs clear, Heart RRR. Blood glucose 140.
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| 41 | 2021-03-24 | fainting | Nausea, dizziness, and faint. Checked out by the paramedics and then went home. |
| 41 | 2021-03-24 | heart rate increased, blood pressure increased |
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "...
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RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
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| 41 | 2021-03-24 | coughing up blood |
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu...
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Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-03-24 | coughing up blood |
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an...
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Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-03-24 | fainting |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 41 | 2021-03-24 | hypertension |
Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hyp...
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Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hypertension (209/152), came down to 201/140, and again to 165/100. A pillow was placed under her and her legs/feet were elevated. While in our care, patient was provided and consumed 5 bottles of water and 2 packs of peanut butter crackers (pt is prediabetic and only thing she had consumed all day was a double espresso). She complained of oscillating between hot and cold... when she was cold she was provided a blanket. Patient refused our offer to call EMS. Patient consented to us reaching out to her physician, but they did not answer and patient refused our offer to leave a voicemail for her doctor. Patient left area and went to restroom to evacuate bowels and reported she felt significantly better. Patient stated she did not have a BP cuff at home and was provided both a BP cuff and acetaminophen and was advised to check her BP in a couple of hours. She walked out on her own and was advised to contact her doctor and that we would call her later that evening. When contacted that evening, she reported she was doing well.
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| 41 | 2021-03-25 | chest discomfort |
3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'. A/O, W/D, RESP REG WIT...
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3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'. A/O, W/D, RESP REG WITH EASE. NO DIFFICULTY SWALLOWING. NO ACUTE/OBVIOUS DISTRESS. 7:15 AMBU TO BATHROOM. 7:26PM STATES SHE 'FEELS BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. RESP REG WITH EASE. NO DISTRESS NOTED. 3-25-21 8:15 TC: PT STATES SHE IS 'ALL BETTER TODAY'.
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| 41 | 2021-03-25 | chest pain |
I experienced left sided chest pain 2 days after the vaccination lasting 2 days. Then 4 days after t...
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I experienced left sided chest pain 2 days after the vaccination lasting 2 days. Then 4 days after the vaccine, some back/Lung pain causing difficulty and painful breathing lasting for at least 3 days. I went to the Emergency department 6 days after the vaccination. I am reporting this information on the 8th day of vaccination.
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| 41 | 2021-03-25 | chest discomfort |
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star...
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Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.
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| 41 | 2021-03-25 | arrhythmia, palpitations |
Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 day...
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Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 days after injection. Ongoing as of 3/26/221
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| 41 | 2021-03-27 | palpitations, heart rate increased |
Heart beats really rapidly for about a minute a couple times a day. Also, feel small heart palpitati...
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Heart beats really rapidly for about a minute a couple times a day. Also, feel small heart palpitations that I've never experienced throughout the day.
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| 41 | 2021-03-31 | fast heart rate |
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens...
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Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
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| 41 | 2021-04-01 | loss of consciousness |
started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you ...
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started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization . There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization. Information on the lot/batch number has been requested.
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| 41 | 2021-04-12 | blood clot |
Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 we...
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Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 weeks. Placenta showed 2 blood clots restricting blood flow at delivery. Mother with no known clotting disorders. 2 prior healthy infants.
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| 41 | 2021-04-13 | chest pain, pulmonary embolism |
Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Emb...
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Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment
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| 41 | 2021-04-15 | deep vein blood clot |
Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started wit...
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Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.
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| 41 | 2021-04-15 | fibrin d dimer increased |
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp...
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he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
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| 41 | 2021-04-16 | pulmonary embolism |
Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in bo...
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Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).
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| 41 | 2021-04-16 | chest discomfort |
Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occ...
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Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-04-19 | heart rate increased |
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that...
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Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
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| 41 | 2021-04-20 | chest discomfort, palpitations, heart flutter, chest pain |
Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitation...
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Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report. Information on the lot/batch number has been requested.
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| 41 | 2021-04-21 | heart rate increased |
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -...
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- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
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| 41 | 2021-04-24 | pulmonary embolism, deep vein blood clot |
DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to ext...
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DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) . A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years. No other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner. The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
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| 41 | 2021-04-24 | fainting |
Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Pati...
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Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-04-24 | excessive bleeding |
hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme majo...
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hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
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| 41 | 2021-04-27 | excessive bleeding |
Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove ...
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Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to ER due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C. She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy.
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| 41 | 2021-04-27 | skin turning blue |
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react...
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asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-04-28 | loss of consciousness, lightheadedness, pallor |
Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing lo...
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Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 41 | 2021-04-30 | excessive bleeding |
I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contacta...
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I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.
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| 41 | 2021-04-30 | excessive bleeding |
bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shou...
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bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.
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| 41 | 2021-04-30 | hypertension, pulse abnormal |
didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a sp...
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didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-04-30 | cerebrovascular accident, hypertension, heart rate increased |
migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; b...
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migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.
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| 41 | 2021-05-07 | hypertension |
urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood ...
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urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021477200 mother/baby
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| 42 | 2020-12-31 | loss of consciousness, fainting |
Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, co...
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Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.
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| 42 | 2020-12-31 | arrhythmia, atrial fibrillation, heart rate increased |
Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was fo...
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Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon). Treated in emergency room after EKG confirmed a-fib. Received potassium and flecainide and converted to normal sinus rhythm after several hours.
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| 42 | 2021-01-02 | palpitations, hypertension, fast heart rate |
11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patie...
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11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS
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| 42 | 2021-01-02 | palpitations |
After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat,...
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After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....
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| 42 | 2021-01-03 | chest discomfort |
Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50m...
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Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)
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| 42 | 2021-01-03 | blood pressure increased |
Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 min...
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Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.
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| 42 | 2021-01-03 | chest discomfort | Patient complained of shortness of breath, chest tightness, and throat closure |
| 42 | 2021-01-04 | palpitations, blood pressure increased |
About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt li...
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About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.
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| 42 | 2021-01-04 | nosebleed |
About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI...
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About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-04 | palpitations |
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz...
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Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
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| 42 | 2021-01-05 | chest pain |
12 hours after injection, developed swelling at injection site that increased over two days to be ab...
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12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.
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| 42 | 2021-01-06 | fainting, hypotension, skin turning blue |
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha...
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12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
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| 42 | 2021-01-06 | heart rate increased, chest pain, chest discomfort |
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m...
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About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
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| 42 | 2021-01-06 | chest pain, fast heart rate |
Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She...
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Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.
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| 42 | 2021-01-06 | palpitations |
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re...
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Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
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| 42 | 2021-01-07 | chest pain |
01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went aw...
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01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went away. 01/08/2021- Woke up at 11AM with slight pulsing pains again in left side of chest. no medicine taken. It came and went as the day went on - felt similar to heartburn. Thought I should report cause I've never woken up with these pains prior to this.
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| 42 | 2021-01-07 | heart rate increased |
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a...
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1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
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| 42 | 2021-01-07 | fainting | BP: 120/70 - Lightheadedness, syncope. Outcome: rested, stabilized. |
| 42 | 2021-01-07 | excessive bleeding |
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -...
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Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
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| 42 | 2021-01-07 | blood pressure increased, heart rate increased |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | blood glucose increased |
Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours l...
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Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.
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| 42 | 2021-01-07 | fast heart rate | Headache, Myalgia, Fever, Tachycardia, temp 104.0, chills, fatigue Narrative: |
| 42 | 2021-01-07 | palpitations |
Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged t...
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Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.
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| 42 | 2021-01-07 | blood pressure increased |
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o...
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Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
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| 42 | 2021-01-08 | lightheadedness, palpitations, chest pain, blood pressure increased, fast heart rate | Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain |
| 42 | 2021-01-08 | heart rate increased |
Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She ...
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Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms
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| 42 | 2021-01-09 | palpitations, fast heart rate |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-09 | chest discomfort |
Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extrem...
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Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.
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| 42 | 2021-01-10 | lightheadedness, chest pain | Headache, chest pain, fatigue, feeling of near syncope |
| 42 | 2021-01-10 | chest discomfort |
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi...
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Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
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| 42 | 2021-01-11 | chest pain |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | fainting |
Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment. given I...
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Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment. given IV fluids, Benadryl, famotidine, methylprednisolone, IV fluid bolus and 02 along with reglan and Zofran. Total ED stay approximately 4 hours
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| 42 | 2021-01-11 | fainting | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | fast heart rate, hypertension |
TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PAT...
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TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY
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| 42 | 2021-01-11 | loss of consciousness |
The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had ...
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The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.
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| 42 | 2021-01-11 | heart rate increased |
Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken ...
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Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.
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| 42 | 2021-01-11 | palpitations |
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she...
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While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm". Â Pt stated that her heart felt like it was "pounding". Â VS: 162/96, 99% RA, HR in the 70's. Â Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home. Â The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist. Â Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications. Â
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| 42 | 2021-01-11 | blood pressure increased |
patient began to have headache (pressure back of head), some shortness of breath with an elevated bl...
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patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated
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| 42 | 2021-01-12 | hypertension, heart rate increased |
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st...
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10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
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| 42 | 2021-01-12 | chest discomfort |
About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy.....
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About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.
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| 42 | 2021-01-12 | blood pressure increased |
Patient initially experienced tingling in left hand right after injection. This resolved but then sh...
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Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
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| 42 | 2021-01-12 | pallor |
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an...
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wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
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| 42 | 2021-01-13 | heart rate increased |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-13 | chest discomfort |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-13 | hypertension, hypertension | Systemic: dizzy and bp high 149/95 |
| 42 | 2021-01-13 | blood pressure increased |
The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starti...
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The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.
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| 42 | 2021-01-13 | lightheadedness |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | chest discomfort |
chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous...
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chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021). No treatment was received for the events. All events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-13 | palpitations |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-14 | lightheadedness, hypotension |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | hypotension, lightheadedness |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | chest discomfort |
Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, admini...
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Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, administration time=02:00 PM, dose number=2/administration date=18Dec2020, administration time=11:00 AM, dose number=1; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 14:00 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to penicillin. Concomitant medication included acyclovir (ACYCLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 0140; expiry date: unknown) in the right arm on 18Dec2020 at 11:00 AM, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced chest tightness. On the inside, she felt like she needed to exhale. The patient did not receive treatment for the event. Outcome of the event chest tightness was not recovered.
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| 42 | 2021-01-14 | palpitations |
Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple...
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Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple minutes. No interventions performed
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| 42 | 2021-01-14 | blood pressure increased |
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Contin...
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Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
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| 42 | 2021-01-14 | lightheadedness | Vaso vagal response. No LOC. No additional medical treatment required. |
| 42 | 2021-01-15 | chest discomfort |
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh...
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Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
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| 42 | 2021-01-15 | heart flutter |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-17 | chest pain, fast heart rate |
10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shor...
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10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
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| 42 | 2021-01-17 | pallor |
AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NA...
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AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER
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| 42 | 2021-01-17 | pallor |
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,...
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About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
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| 42 | 2021-01-17 | chest discomfort |
At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, d...
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At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, drop in peak flow (~20% decrease) and coughing. This was treated with a single dose of Albuterol 2.5mg/3mL nebulized with complete resolution. No further shortness of breath. (Concurrently, also had mild tiredness and muscle aches.)
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| 42 | 2021-01-17 | blood pressure increased |
Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to...
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Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to normal.
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| 42 | 2021-01-17 | palpitations |
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch...
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Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
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| 42 | 2021-01-17 | blood pressure increased |
Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room fo...
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Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room for high BP and was given 2 doses of Benadryl, was sent home after 1 hr, 2nd day reports severe HA which resolved same day with Aleve, today 1/18 reports still experiencing hives & continues to take PO Benadryl daily
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| 42 | 2021-01-18 | heart rate increased, chest discomfort |
Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my che...
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Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.
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| 42 | 2021-01-18 | blood pressure increased, lightheadedness, heart rate increased |
Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, ...
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Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.
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| 42 | 2021-01-18 | blood pressure increased | Uncontrolled elevated BP ranging 192/102 on multiple readings. |
| 42 | 2021-01-19 | palpitations | Heart was racing and lightheadedness |
| 42 | 2021-01-19 | heart rate increased |
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid...
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Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
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| 42 | 2021-01-19 | hypertension |
Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no o...
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Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue
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| 42 | 2021-01-19 | chest pain | substernal chest pain and pain in axillary region of rib cage on both sides |
| 42 | 2021-01-20 | heart rate increased |
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu...
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Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
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| 42 | 2021-01-20 | fast heart rate | Tachycardia/shortness of breath 160-180?s sustained 20 min |
| 42 | 2021-01-21 | heart rate increased, ischemic chest pain |
Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up wit...
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Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded
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| 42 | 2021-01-22 | fainting, chest pain |
Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetit...
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Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.
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| 42 | 2021-01-22 | blood pressure increased, pallor |
While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called t...
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While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called to her side. Her BP was elevated and she remained pale & dizzy. She was taken to ED. No medications were administered.
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| 42 | 2021-01-23 | fast heart rate, chest discomfort, chest pain, hypertension |
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ...
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Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
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| 42 | 2021-01-24 | chest pain, fast heart rate, heart rate increased |
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ...
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About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
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| 42 | 2021-01-24 | fainting |
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c...
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Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-24 | loss of consciousness | Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes. |
| 42 | 2021-01-24 | heart rate increased | RAPID HEART RATE 160-180, NO INTERVENTION. |
| 42 | 2021-01-24 | chest discomfort |
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I...
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Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
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| 42 | 2021-01-24 | palpitations |
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he...
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Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
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| 42 | 2021-01-25 | chest discomfort |
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig...
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1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
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| 42 | 2021-01-25 | fast heart rate, chest pain |
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, h...
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Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
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| 42 | 2021-01-26 | platelet count decreased |
After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet coun...
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After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet count. I have no pre existing conditions before taking the vaccine . Last year my platelet count was 166. After 1 week of taking the second shot of vaccine my platelet count dropped to 129. After 5 days later I had reexamined the cbc and the platelet dropped to 121. I believe it is a reaction to the vaccine.
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| 42 | 2021-01-26 | palpitations | Heart issues, palpitations, shortness of breathe. Seeing physician. reported this on 1/27/2021. |
| 42 | 2021-01-26 | nosebleed |
Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at ...
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Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms
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| 42 | 2021-01-26 | heart rate increased, palpitations, blood pressure increased |
heart started to race; tingling sensation from her left arm that radiated to all over her body to th...
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heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-27 | chest pain |
Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an h...
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Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an hour
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| 42 | 2021-01-27 | chest discomfort, fast heart rate |
Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not impr...
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Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not improves with NSAID. Tachycardia, headache, insomnia, fatigue, chest pressure.
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| 42 | 2021-01-27 | palpitations |
after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse a...
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after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse and noticed it was 120. Pt stated she felt dizzy but nothing else. walked pt over to vehicle where her husband was parked. pt decided to be taken to ED in her own vehicle for further eval
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| 42 | 2021-01-27 | chest discomfort, heart rate increased |
chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I s...
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chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I stood up; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: unknown), intramuscular on the right arm on 29Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included occasional premature ventricular contractions (PVCs) and high blood pressure. The patient had no known allergies, is not pregnant and had no COVID prior vaccination. Concomitant medications included vitamin C [Ascorbic Acid] (VITAMIN C [ASCORBIC ACID]), vitamin D3 (VITAMIN D3), bromelains (BROMELAIN), quercetin (QUERCETIN), zinc (ZINC), acetylcysteine (NAC [ACETYLCYSTEINE]) and Probiotic. The patient had no other vaccines in four weeks. On 06Jan2021 at 21:00, the patient experienced chills all day but no fever. Around 9pm, her heart rate shot up to the 120s and she had chest pressure and felt like she couldn't breathe every time she stood up. When she laid down, it was better. These lasted about 3 hours. She had some very mild shortness of breath twice after this on the 7th and 9th, but it was not nearly as bad as on the 6th. The patient did not take any medication when these happened. The patient tested for COVID post-vaccination (07Jan2021) through COVID-19 PCR (Nasal Swab) which resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
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| 42 | 2021-01-27 | loss of consciousness | nausea, passing out |
| 42 | 2021-01-27 | palpitations |
palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (p...
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palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.
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| 42 | 2021-01-28 | pallor, lightheadedness |
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnanc...
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Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
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| 42 | 2021-01-28 | chest pain, chest discomfort |
Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 h...
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Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
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| 42 | 2021-01-29 | heart rate increased |
Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. ...
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Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. Passed by itself.
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| 42 | 2021-01-29 | palpitations |
Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got...
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Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got up to leave and then felt palpitations; VS: BP 122/81, HR 74, O2 sat 97% on RA Pulse regular She sat down and symptoms resolved. Patient then left to go home, and was instructed to seek help if she felt worse.
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| 42 | 2021-01-30 | blood pressure increased |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-01-30 | heart rate increased | Temperature 99.4, extreme fatigue, rapid heartbeat |
| 42 | 2021-02-01 | palpitations |
Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolve...
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Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolved within 12 hours
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| 42 | 2021-02-01 | palpitations |
approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my...
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approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)
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| 42 | 2021-02-01 | hypertension |
high blood pressure/her blood pressure is 165/114; This is a spontaneous report from a contactable c...
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high blood pressure/her blood pressure is 165/114; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK9231), via an unspecified route of administration in the left arm on 12Jan2021 at 09:30 as a single dose for COVID-19 immunization. The patient had no relevant medical history and had no concomitant medications. History of all previous immunizations with Pfizer Vaccine considered as suspect was reported as none (this was the first dose received), did not have additional vaccines administered on the same date as the Pfizer vaccine, and did not have any prior vaccinations within four weeks. The patient mentioned that after getting the first shot of the COVID-19 vaccine, her blood pressure was 165/114 in the morning of 14Jan2021. She has never had high blood pressure and wanted to know if this was normal after getting the vaccine. The last three days she has been taking her blood pressure and it had been high. On 18Jan2021, the patient's blood pressure was 165/108. Her previous blood pressure readings have been in the 160's over 108-114. Reiterated that she has never had high blood pressure before. She was scheduled to get second dose on 02Feb2021. The event did not require a visit to the Emergency Room or Physician's Office and she has not gone yet to the hospital. Everyone wanted her to, but she did not want to go. She stated she did not like hospitals. Outcome of the event was not recovered.
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| 42 | 2021-02-03 | pallor |
(This RN was not direct observer of initial incident. Initial events as reported by initial respondi...
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(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department
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| 42 | 2021-02-04 | haemoglobin decreased |
On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On...
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On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet. Went to bed, the feeling went over her entire body. The sensation continued on her hands and her feet. She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low. Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy. He did blood work and going to check what would trigger the neuropathy pain.
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| 42 | 2021-02-05 | blood pressure increased |
Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccin...
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Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccination. Today 2/5/2021, 2nd vaccination approximately 0800. Started to feel chills and numbness/tingling in left arm which was vaccination side. Then developed numbness/tingling in both legs below the knees. Placed on pulse oximeter and vitals monitored. Vital signs normal although initially blood pressure elevated but came back down. ~0830 Patient placed on gurney, covered with warm blankets and given oral medications: diphenhydramine 25mg, famotadine 20mg, acetaminophen 500mg. At 0930 patient taken to ED as symptoms were not resolving. Patient had difficulty transferring from gurney to wheelchair for transfer due to leg numbness.
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| 42 | 2021-02-07 | blood pressure increased |
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi...
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blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-02-08 | heart rate increased |
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous...
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anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-09 | cardiac arrhythmia |
I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, p...
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I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, pre-ventricular contractions. I had work up done. I had to get an IV of magnesium. I still have those symptoms intermittently and I am being followed up with my cardiologist.
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| 42 | 2021-02-09 | palpitations |
I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minute...
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I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 42 | 2021-02-09 | blood pressure increased |
I have lightheaded; elevated blood pressure; elevated blood pressure; This is a spontaneous report f...
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I have lightheaded; elevated blood pressure; elevated blood pressure; This is a spontaneous report from a Pfizer sponsored program. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), intramuscular on 21Jan2021 08:00 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure elevated. Concomitant medications were none. When she took the first dose of the vaccine on Thursday 21Jan2021, about 2 minutes after receiving the injection she got really light-headed. They wanted her to be assessed by an EMT and when they assessed her, she had an elevated blood pressure. Last time her blood pressure was taken it was elevated and she had not had it checked since then. She was asking if it was safe to get the second dose. Patient declined any medical treatment, she was told to eat food and drink water. Outcome of lightheadedness was resolved on 21Jan2021. Outcome of blood pressure elevated was unknown.
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| 42 | 2021-02-09 | chest discomfort, palpitations |
shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneou...
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shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering. The information on the batch number has been requested.
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| 42 | 2021-02-10 | lightheadedness, heart rate increased |
5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to ...
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5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to the floor near syncope. Laid down and took off mask for air. Was offered water and Benadryl. Drank some water then felt better.. Refused the Benadryl. 10 minutes after someone noticed a possible rash on my forehead. Went ahead and took some Benadryl. Later that night had same feelings.. fast heart rate and dizziness. The next day development flu like symptoms with fever up to 102.9. Took a half Tylenol. The next day just felt achy . The day after that had diarrhea.
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| 42 | 2021-02-10 | chest discomfort |
TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD...
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TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD SOME TRANSIANT CHEST TIGHTING RX 25MG BYNADRYL, 16OZ WATER
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| 42 | 2021-02-11 | palpitations | Pt described a swollen tongue, racing heart, tingling throat. |
| 42 | 2021-02-14 | fainting |
Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and mus...
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Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and muscle pain, shivering, sweating, freezing, low grade fever, severely weak, collapsed to the floor the first morning after receiving the 2nd dose shot bc she couldn?t make it back upstairs on her own. Injection site was red and swollen with a defined border. Severe pain at injection site as well. All symptoms listed to this point lasted for 48 hrs. After that severe joint and muscle pain diminished and pain medication (ibuprofen 800mg) was no longer being taken. However, severe arm soreness, tenderness, redness, swelling and itchiness remained/started on day 3. Itchiness spread from only the arm to entire body by day four. Patient went to hospital on day 4 but did not get admitted because they wanted to care for her in the Covid unit without knowing if she had Covid or not. Patient administered self-care by taking Benadryl continuously for approximately 48 hours starting on day 4. She stayed home after attempting to get help from redlands community hospital ER because she didn?t feel comfortable being told she could only get care if she went into the covid unit without a covid test being offered or done to her first. Patient was bedridden and severely sick from February 1 through February 7 2021. Feb 11 2021 patient took a covid test to rule out covid as the reason she felt so bad. Test result for covid was negative.
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| 42 | 2021-02-14 | chest discomfort |
chest tightness and nausea, hyperventilation, 1st dose pfizer vaccine @ 1610, benadryl 25 mg IM give...
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chest tightness and nausea, hyperventilation, 1st dose pfizer vaccine @ 1610, benadryl 25 mg IM given
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| 42 | 2021-02-14 | haemoglobin decreased | developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0. |
| 42 | 2021-02-15 | chest pain, chest discomfort | Chest pressure/ pain |
| 42 | 2021-02-15 | blood glucose increased |
Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) PO...
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Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment
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| 42 | 2021-02-15 | hypertension |
I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I wen...
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I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I went to Clinic - walk-in care and was seen - the day of the 7th and I went back on the 9th (because more areas popped up). I developed extreme anxiety. The extreme anxiety lasted for about a week. I was seen in ER - twice (Jan 14 and 15)- I was treated with anxiety medicine for anxiety and panic attacks- Essoxer and Xanex. Petechiae rash is still there - lightened up but it's still there some. Did not get the second vaccine per doctor's advice.
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| 42 | 2021-02-15 | oxygen saturation decreased, chest discomfort |
Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help....
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Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help. It lasted about 4 hours. Shooting nerve pain through my body for several days. Overall sluggish for two days, body aches, exhaustion.
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| 42 | 2021-02-15 | cerebrovascular accident |
Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk fa...
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Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.
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| 42 | 2021-02-18 | fast heart rate, blood pressure fluctuation |
Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with...
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Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of neck. 2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
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| 42 | 2021-02-18 | palpitations |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | hypertension, inflammation of the pericardium, blood pressure increased |
Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses oth...
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Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses other then the vaccine. Developed myalgia, severe headache, and slightly elevated blood pressures 24 hours post second vaccine. Then 4 weeks later acute pericarditis.
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| 42 | 2021-02-21 | palpitations | Palpaltations and dizziness |
| 42 | 2021-02-21 | heart attack, fibrin d dimer increased, inflammation of the pericardium, chest pain |
Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Stat...
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Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.
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| 42 | 2021-02-22 | fainting |
I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as...
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I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.
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| 42 | 2021-02-22 | blood pressure increased, heart rate irregular, heart rate increased |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-22 | vaginal haemorrhage | Vaginal bleeding about an hour after first dose |
| 42 | 2021-02-23 | chest pain |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-24 | chest discomfort |
10 minutes after vaccination she developed mid-sternal chest tightness. No other allergic symptoms ...
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10 minutes after vaccination she developed mid-sternal chest tightness. No other allergic symptoms or SOB
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| 42 | 2021-02-24 | ischaemic stroke | Ischemic stroke |
| 42 | 2021-02-24 | blood pressure increased, chest discomfort |
complaining of mild tightness of chest immediately following vaccination. Pt stated that tightness ...
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complaining of mild tightness of chest immediately following vaccination. Pt stated that tightness not uncommon with history of asthma and anxiety. Denied : any itching or allergy related complaints, any respiratory difficulty.
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| 42 | 2021-02-24 | fast heart rate, hypertension, chest pain |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-25 | chest discomfort |
1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen...
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1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen at ICC same day; was COVID tested at ICC negative
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| 42 | 2021-02-25 | chest discomfort, palpitations | Complained of chest tightness, flushed and palpitations, self resolved |
| 42 | 2021-02-25 | chest discomfort |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-26 | chest discomfort |
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm...
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Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
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| 42 | 2021-02-26 | palpitations, hypertension |
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very...
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extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
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| 42 | 2021-02-27 | heart rate increased |
9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue...
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9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
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| 42 | 2021-02-28 | nosebleed | Bloody Nose, Headache, Body aches, Chills, Back Pain |
| 42 | 2021-02-28 | chest discomfort, heart rate increased, palpitations |
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou...
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Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
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| 42 | 2021-03-01 | chest discomfort, fainting |
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic we...
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About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
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| 42 | 2021-03-01 | fainting |
Patient with history of allergy to azithromycin and sulfa drugs. Experienced lightheadedness, dizzy...
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Patient with history of allergy to azithromycin and sulfa drugs. Experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination. Nurse Lead and observer present. Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty. Symptoms improving after placed on gurney and water provided. Pt reports not having had eaten before being vaccinated today. Water given and patient continued to be observed for a total of 45 minutes. Pt discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA.
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| 42 | 2021-03-02 | chest pain |
18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She w...
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18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She was not anxious. She was in between classes of teaching virtually
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| 42 | 2021-03-02 | blood glucose increased |
I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than...
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I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 42 | 2021-03-04 | heart rate increased |
chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable ...
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chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-06 | chest discomfort |
Patient received her second dose of the Pfizer Covid-19 vaccine at 1634 this date. At about 1640 sh...
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Patient received her second dose of the Pfizer Covid-19 vaccine at 1634 this date. At about 1640 she began to experience chest heaviness, a scratchy throat, and dizziness. Patient had told clinic staff that she had a similar experience at home after receiving her first dose of the vaccine last month. At that time she took 50 mg Benadryl by mouth and her symptoms resolved. The clinic staff had been monitoring the patient for indications of a reaction and when she did start to experience her symptoms, she was moved into a vaccination cubical for privacy. Vital signs were recorded and the patient used her own Albuterol rescue inhaler once. 50 mg Benadryl was administered IM in the right deltoid by Paramedic at 1658. By 1705, patient stated her symptoms were resolving. She called her husband by cell phone to arrange for him to come get her. Vital signs were re-checked and patient was given cool water to sip. Her husband arrived at about 1710. Both the patient and her husband were advised to be cognizant of a return of any symptoms and to seek medical attention if symptoms returned or worsened. Patient was released to the care of her husband at 1720
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| 42 | 2021-03-07 | palpitations |
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel...
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10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
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| 42 | 2021-03-08 | fainting |
Patient experienced an episode of syncope and fainted twice during observation period. Offered oxyge...
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Patient experienced an episode of syncope and fainted twice during observation period. Offered oxygen and called 911 and EMS arrived. Patient evaluated by EMS and was recommended to go to ER with EMS but she declined. Patient was counseled on anticipated side effects. She was recommended to follow up with PCP and describe what took place and what she experienced. The timespan that this took place was 20 minutes and she improved and able to speak with assistance. Her husband was present.
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| 42 | 2021-03-08 | palpitations |
Pt reporting SOb and palpitations. Her vital signs were normal. she felt better after drinking juice...
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Pt reporting SOb and palpitations. Her vital signs were normal. she felt better after drinking juice.
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| 42 | 2021-03-08 | fast heart rate | Tachycardia, Urticaria |
| 42 | 2021-03-09 | palpitations |
4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with ...
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4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with EMTs for 1.5 hours until I was comfortable to leave. Heart rate came back to normal over this time period. There were still moments when I felt flush/faint-like.
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| 42 | 2021-03-09 | chest discomfort, palpitations |
After an hour I had the vaccine I started having fast heart palpitations and my chest started to com...
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After an hour I had the vaccine I started having fast heart palpitations and my chest started to compress. My blood pressure was 176/148 and I had to go to the ER.
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| 42 | 2021-03-10 | fainting, ischemic chest pain |
Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck....
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Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose. Nurses put me in wheelchair and took me to bed. Kept me for 30 mins. Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.
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| 42 | 2021-03-11 | fainting |
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f...
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Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
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| 42 | 2021-03-11 | loss of consciousness |
Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just...
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Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just about 30 seconds swollen lymph node under right arm - persisting on day 3 post injection brain fog - lasted 2 days
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| 42 | 2021-03-11 | pallor |
The logistician from station 3 alerted the observation area that a patient was not feeling well. Th...
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The logistician from station 3 alerted the observation area that a patient was not feeling well. The patient was sitting on the chair. She looked pale. She complained of feeling dizzy and lightheaded (went away 2 mins after getting the shot) and blurry vision (went away 5 seconds after getting the shot) Blood pressure: 118/76; Pulse 68. O2 sat unable to read d/t nail polish. Good capillary refill. She felt better after 20 minutes. She rested laying down with her feet elevated for 20 minutes. She sat down for 15 minutes and stood up for 5 minutes with no dizziness/lightheadedness. Patient texted that she arrived home safely and felt fine.
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| 42 | 2021-03-12 | palpitations |
Covid arm rash which went away, but now..... non stop heart palpitations from 5-8pm. Very scary. The...
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Covid arm rash which went away, but now..... non stop heart palpitations from 5-8pm. Very scary. These started a few days after the injection. Never had one in my life before this shot.
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| 42 | 2021-03-13 | hypertension |
Hypertension of 162/118 with heart rate of 130 being at 1335. Normal blood pressure is around 120/80...
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Hypertension of 162/118 with heart rate of 130 being at 1335. Normal blood pressure is around 120/80 & resting heart rate of 70. Swimmy headed. But laughing and joking. Observed for 10 minutes, transferred to ER from vaccine site on campus. Triage bp was 145/100, hr of 112. Time elapsed between vitals taken was 17 minutes. EKG performed. Was not informed of results. Monitored for next several hours. Was asked to drink approximately 32 oz of apple and water. Given crackers to eat. Discharged from ER at approximately 1800. Bad headache same night into next day.
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| 42 | 2021-03-13 | chest pain |
sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip i...
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sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that. Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose tip feels like it?s freezing and has numbness and a runny suddenly on day 3.
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| 42 | 2021-03-14 | hypertension, chest pain, chest discomfort |
Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she co...
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Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she complained of chest pain/tightness. She described the pain as dull. She stated that she has a history of allergy to penicillin. She also has high blood pressure, but missed a dose today. She takes medication for anxiety as well. She was immediately evaluated by EMT personnel on site, and ?911? was called. She was evaluated by the emergency personnel for 30 minutes inside the ambulance and then transferred to the hospital
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| 42 | 2021-03-14 | pallor, hypotension |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-03-15 | chest discomfort |
Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was place...
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Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was placed in supine position, was tearful and lethargic for first 4-5 minutes, never loss consciousness. After 10 minutes in supine position she reported feeling back to normal.
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| 42 | 2021-03-15 | pulmonary embolism | n/v, chills, SOB, pulmonary embolism, pericardial effusion |
| 42 | 2021-03-16 | fast heart rate | Tachycardia. Heart Rate in the 130s at rest. |
| 42 | 2021-03-17 | chest discomfort | DIZZINESS. CHEST DISCOMFORT |
| 42 | 2021-03-18 | vaginal haemorrhage |
Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours...
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Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours, the spotting increased to a light bleeding with fatigue and cramping in the abdomen and has remained this way. I am still currently bleeding. My last period ended 3/7/21. My period is never irregular.
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| 42 | 2021-03-18 | chest pain |
Patient reported low grade itching almost immediately after the second dose on 3/17/21 and continued...
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Patient reported low grade itching almost immediately after the second dose on 3/17/21 and continued though date of incident. Headache started 3/18/21 and continued through date of incident. While sitting at work on 3/19/21, patient reported a sudden onset of sharp pain in her left sternum. CHS Healthcare Paramedic conducted an assessment and reports no dizziness or nausea, clear breath sounds O2 WNL, non-smoker, chest pain with a deep breath and while at rest. Provided 324 mg aspirin and 0.4 mg nitro with no resolution of symptoms. Patient transported to Unity Hospital for further evaluation.
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| 42 | 2021-03-18 | palpitations |
Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PC...
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Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PCP if symptoms continue
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| 42 | 2021-03-19 | pulmonary embolism, deep vein blood clot |
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ...
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Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
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| 42 | 2021-03-19 | hypertension |
Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the ...
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Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the base of her throat and down her arms. Pt denied trouble breathing, drooling, speaking, or swelling. Paramedics on scene escalated the situation. Pts pulse was 98 bpm with a regular rhythm (12 lead EKG was performed). Pt was hypertensive (BP 177/104). Paramedic on scene continued to use medical language and amplify the situation. An ambulance was called. I offered to have pt wait 10 minutes and then recheck bp, as the rest of her symptoms had resolved. Paramedics encouraged patient that it was "her decision to take the ambulance, however they were concerned about a stroke with a bp that high". Pt left in an ambulance. Will f/u in a couple days.
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| 42 | 2021-03-19 | hypertension, heart rate increased |
Within minute of the injection, patient had severe headache. She had dizziness and became very fatig...
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Within minute of the injection, patient had severe headache. She had dizziness and became very fatigued. She could not stand up and it was hard to understand her. Within 10 minutes of the injection, patient became very nauseated. They brought her a trash bucket and she hd dry heaved twice. Pharmacist called the EMT around 6pm. The two EMTs took her blood pressure and pulse. Both were extremely high. Blood pressure was 172/96. They recommended that patient should be transported to local ER at the hospital. They put her in the ambulance andtransported her to hospital. She remained at the hospital for 5 hours. Once blood pressure and pulse came down, she was allowed to leave.
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| 42 | 2021-03-21 | palpitations | Flushing, palpitations |
| 42 | 2021-03-21 | pallor, blood glucose increased, very slow heart rate, fainting |
Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10...
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Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10-15 minutes after injection (no history of reaction after first injection.) History of underlying cardiac problems, hypertrophic myopathy, V-Tach. Post injection syncopal episode; patient was bradycardic rate 40, pale, weak, alert & oriented x 4 . Medical staff on site ,care immediately turned over to staff, IV established, Fluids given, BS checked. Sustained bradycardia in 40s for approximately 10 minutes raising to mid 50's following fluid. Patient has a defibrillator/pacer stated that no lower demand set. Pacer for V-tach. Patient stated her defibrillator has fired over 200 times but did not feel defibrillator fire at time of episode. Transferred to Hospital as per patient preference stated this is where cardiologist and records are, cleared through Base prior to transferring. Seen in ED then discharged later that afternoon.
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| 42 | 2021-03-21 | cardiac arrest |
Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (p...
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Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested.
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| 42 | 2021-03-21 | lightheadedness |
Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 ...
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Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 Subjective is a 42 y.o. female who was seen at today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience shakiness, feeling faint diaphoresis.. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to collapse and rapid progression of symptoms. PMH: HTN (losartan), zoloft and medications for allergies and on ocp. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + shakiness: Previous Reactions: hx of vasovagal to blood work procedures. Hx to vaccines as well but had not had any problems for a while. Objective Vitals Vitals: 03/22/21 1140 Resp: (!) 58 SpO2: 98% pt refused. states bp measurements make her pass out Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Comments: Hands shaking. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Abnormal findings above improved after laying patient down flat. Pt feels better and was able to progressively sit up in the chair without reoccurrence of symptoms. Assessment/Plan Treatment included: water and rest Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Resolution of symptoms, suspect vasovagal reaction. She is back to base line. Monitored in bay for approx 10 mintues. Pt able to ambulate w/o difficulty or w/ assistance. Pt with husband for discharge. He will drive home. Follow up with pcp as needed. Both patient and pt's husband express appreciation of care today.
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| 42 | 2021-03-21 | hypotension, palpitations |
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches +facial tingling: Previous Reactions: Denies Objective Vitals Vitals: 03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge. PA-C Electronically Signed 3/22/2021 9:02 AM
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| 42 | 2021-03-22 | palpitations, lightheadedness |
Dizziness & palpitations immediately post vaccine administration; resolved without medical intervent...
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Dizziness & palpitations immediately post vaccine administration; resolved without medical intervention. Near syncope.
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| 42 | 2021-03-22 | vaginal haemorrhage |
Irregular vaginal bleeding & menstrual type cramps. Started approximately 48 hours after receiving v...
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Irregular vaginal bleeding & menstrual type cramps. Started approximately 48 hours after receiving vaccine. Has continued on & off since receiving vaccine, usually lasting 1-2 days, then stopping for 2-4 days.
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| 42 | 2021-03-22 | pulmonary embolism | Pulmonary Emboli, shortness of breath |
| 42 | 2021-03-22 | hypertension, heart rate increased | Rapid pulse, sudden sever headache, high blood pressure. Sent to the ER. |
| 42 | 2021-03-22 | fainting | Syncope following vaccination |
| 42 | 2021-03-23 | lightheadedness |
Date: 3/24/2021 ...
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Date: 3/24/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: asthma r/t seasonal allergies ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + lightheaded: Previous Reactions: none that she is aware of. Had dizziness/lightheaded with ear piercing. Objective Vitals Vitals: 03/24/21 0951 03/24/21 0955 03/24/21 0959 BP: (!) 166/111 (!) 150/100 (!) 142/72 Pulse: 66 57 63 Resp: 18 14 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Speaking full sentences Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slight). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Improved with rest/reclined. Pt able to sit up and stand w/o dizziness/lightheadedness. Assessment/Plan Treatment included: water and close monitoring Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Anxiety mixed with pseudo mild vasovagal syndrome. Pt improved and did well. Pt aware of option of getting her vaccine done here in the bay next time if she would like. Recommend 30 minute observation. F/up with pcp otherwise. 3/24/2021 9:48 AM
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| 42 | 2021-03-23 | palpitations |
onset of heart palpitations and lightheadedness almost 24 hours after injection of 2nd dose in serie...
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onset of heart palpitations and lightheadedness almost 24 hours after injection of 2nd dose in series.
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| 42 | 2021-03-24 | fainting |
patient fainted from seated position in recovery waiting room. she was attended by Dr. for supportiv...
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patient fainted from seated position in recovery waiting room. she was attended by Dr. for supportive care. paramedics were summoned and transported patient to medical center for further treatment. Symptoms were not anaphylaxis; most likely vasovagel response.
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| 42 | 2021-03-25 | palpitations |
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Inte...
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After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing. After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
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| 42 | 2021-03-25 | fainting |
Fainted after getting up to use the restroom in the middle of the night. Fainting resulted in injury...
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Fainted after getting up to use the restroom in the middle of the night. Fainting resulted in injury to my chin and head. Had to get 7 stitches in chin from falling into dresser. I have no memory of falling. Only remember using restroom and be woken up from the floor by my husband.
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| 42 | 2021-03-25 | nosebleed |
I had a severe nose bleed. It started at 2 pm. I could not get it to stop. I went to urgent care and...
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I had a severe nose bleed. It started at 2 pm. I could not get it to stop. I went to urgent care and they were able to get it to stop. But after I got home it started again. I ended up going to the emergency room to get help. I got home from the ER at 11pm. So my nose was bleeding for over 6 hours. I thought I would submit a report because I just found out a blood relative is one of the 37 who developed ITP after her vaccine.
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| 42 | 2021-03-25 | chest discomfort | Tight throat and chest tightness, 12.5mg Benadryl PO provided |
| 42 | 2021-03-26 | pallor |
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s...
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In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
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| 42 | 2021-03-27 | lightheadedness |
Shortly after exiting the vaccination room, the patient felt lightheaded and dizzy and experienced a...
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Shortly after exiting the vaccination room, the patient felt lightheaded and dizzy and experienced an episode of near-syncope. She immediately lay down on the floor. She was sweating profusely. She remained on the floor for approximately 5 minutes with her legs raised and she started to feel better. She was given a bottle of orange juice to drink and was taken to the waiting area where she was observed for another 25 minutes. Patient stated that she felt fine and left the pharmacy.
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| 42 | 2021-03-29 | fainting |
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s...
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extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
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| 42 | 2021-04-01 | chest discomfort, hypertension |
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?...
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Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
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| 42 | 2021-04-02 | heart rate increased, pulmonary embolism, blood clot |
10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not...
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10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not getting better. I got my 2nd shot on day 21 and the day after I got an alert on my Watch regarding resting heart rate exceeding 125bpm and have been inactive for 10mins, so my husband call the doctor's office to make an appointment. They said we could go to the appointment or hospital, so we went to the hospital.
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| 42 | 2021-04-02 | loss of consciousness, fainting, fast heart rate |
like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like bl...
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like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.
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| 42 | 2021-04-03 | lightheadedness, heart rate increased |
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel...
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i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
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| 42 | 2021-04-06 | hypertension, blood pressure increased |
3/11/2021 vaccination Home BP, 3/14 was elevated 3/15 I called the midwives and they told me to come...
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3/11/2021 vaccination Home BP, 3/14 was elevated 3/15 I called the midwives and they told me to come in for monitoring. I had got in range of gestation hypertension and that they should induce me. I was induced on 3/15. This was my second pregnancy, EDD was 3/16, birth weight was 6lbs 9oz. *Post partem; high blood pressure. Magnesium treatment on 3/25
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| 42 | 2021-04-09 | fainting |
fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I ...
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fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband. As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
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| 42 | 2021-04-10 | loss of consciousness |
Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-y...
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Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6204) at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included seizure from 1994 to an unknown date (it is been happening since the patient was a teenager), epileptic from an unknown date and unknown if ongoing. Concomitant medication included levetiracetam taken for seizure from an unspecified start date and ongoing. The patient reported that she had like blackout from, assuming the vaccine the next day on 23Mar2021. It was kind of later in the day and then next day, 23Mar2021, she was just having kind of had a blackout and she was sleeping a lot and may have had a seizure, she was not really sure as she was sleeping a lot and may had a seizure; she was not sure and she was epileptic. The patient was grateful that she got the vaccine. The patient underwent lab test and procedures which included blood test: unknown on an unspecified date. The patient was recovering from the events. Information on the lot/batch number has been requested
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| 42 | 2021-04-12 | chest pain |
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, ...
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Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.
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| 42 | 2021-04-12 | blood clot |
Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This ...
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Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-04-13 | loss of consciousness, cerebrovascular accident |
I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed ...
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I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed unconsciously seizure. The diagnosis are Cerebral Venous Thrombosis (CVT, multiple clots) and Cerebral Venous Sinus Thrombosis (CVST), Focal motor seizure and Cerebral Edema.
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| 42 | 2021-04-14 | heart rate increased |
During 15 minute waiting period, I started having increased heartbeat and overwhelming nausea. I rep...
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During 15 minute waiting period, I started having increased heartbeat and overwhelming nausea. I reported it to the nurse, she took my vitals and my heartbeat was 140-150. My O2 levels were fine and my lungs were clear. Approximately 15 -20 min post vaccine I started having seizures.( I have no history of seizures) I was given Epinephrine, benadryl to calm my body down. It did not change any of my symptoms. I had approx. 5 seizures in the facility before they called the ambulance. I had 3-4 on way to hospital and more once I arrived. I was given ativan to help me relieve the symptoms. I was given a CAT scan and there were no issues as per doctor. I did not have any more seizures and I was sent home. The next morning I had a doctors appointment and started having seizures again. I had about 4 at home, ambulance was called and had more seizures throughout the day. I was admitted to hospital since my seizures were not stopping. I was given another CAT scan and MRI and nothing was was found in either test.
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| 42 | 2021-04-14 | pulmonary embolism |
Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was exper...
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Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.
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| 42 | 2021-04-14 | excessive bleeding | Subdural Hematoma. Blood bleed |
| 42 | 2021-04-17 | blood clot |
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ...
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Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
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| 42 | 2021-04-22 | palpitations, chest discomfort |
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart p...
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Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
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| 42 | 2021-04-24 | chest pain, chest discomfort |
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de...
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Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
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| 42 | 2021-04-27 | pulmonary embolism, deep vein blood clot |
DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient rec...
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DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-04-28 | hypertension |
It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Th...
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It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Then on 4/17 I noticed an internal vibration sensation. This internal vibration sensation persisted and became more frequent (chest, lower half of head predominantly but sometimes whole body as well). April 23 to 25 was happening a lot even while sleeping. On April 23 I went to Urgent care for unexplained high blood pressure, ran tests, and was released. Consulted doctor on April 26 about high blood presure and internal vibration sensation (unclear if related) and ran more tests. Still unclear cause. Will see if symptoms continue to improve.
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| 42 | 2021-04-30 | chest discomfort, palpitations |
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid...
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Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-05-03 | heart attack |
fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101...
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fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-05-04 | pulmonary embolism |
Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from...
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Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from a contactable nurse (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 02Apr2021 11:00, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included esophageal dysmotility, thyroid nodules, ACL tear and ACL repair on 15Apr2021. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO); and paracetamol (TYLENOL), both taken for unspecified indications, start and stop dates were not reported. The patient previously took prochlorperazine (COMPAZINE) and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) at age 42 years, via an unspecified route of administration in the left arm, on 19Mar2021, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was hospitalized on 18Apr2021 with bilateral pulmonary embolism (onset date was 18Apr2021). Treatment for the event included Lovenix. The patient underwent COVID nasal swab on 05Apr2021 and 18Apr2021 which both resulted to negative. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported bilateral pulmonary embolism occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-05-07 | fainting |
14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, ...
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14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-05-07 | chest discomfort |
flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever ...
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flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-05-10 | blood clot |
Blood clot in right calf; This is a spontaneous report received from contactable consumer for hersel...
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Blood clot in right calf; This is a spontaneous report received from contactable consumer for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:15 (Batch/Lot Number: EW0151) as 2nd dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history allergy to penicillin. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 on 21Mar2021 05:15 PM in Left Arm (Batch/lot number: Ep6955) as 1st dose, single for COVID-19 Immunization. The patient experienced blood clot in right calf on 15Apr2021 03:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clot in right calf included Blood thinners. No Hospitalization Prolonged. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.
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| 42 | 2021-05-10 | inflammation of the pericardium |
Diagnosed with pericarditis and admitted to the hospital; This is a spontaneous report from a contac...
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Diagnosed with pericarditis and admitted to the hospital; This is a spontaneous report from a contactable other HCP (patient). A 42-years-old female patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Jan2021 (Lot Number: EL1284) at age of 42 years as single dose for covid-19 immunisation. Medical history included seasonal allergies coconut allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY). Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient developed severe sudden chest pain. Taken to the ER via ambulance. Diagnosed with pericarditis and admitted to the hospital (3 days hopitalization). Given colchicine and high dose NSAIDs. Had to go on short term disability due to the pain. Then given steroids at home. No prior health history and healthy. Received the second dose of the vaccine 3 weeks prior to pericarditis. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered. Follow up attempts needed. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event pericarditis cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-05-10 | palpitations |
My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; T...
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My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 43 | 2020-12-31 | blood clot |
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl...
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Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
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| 43 | 2021-01-02 | palpitations | Racing heart, dizziness, lightheadedness |
| 43 | 2021-01-03 | heart rate increased |
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje...
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Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
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| 43 | 2021-01-03 | body temperature decreased |
Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration ...
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Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration and lasted about 8 hours.
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| 43 | 2021-01-03 | chest pain |
First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever c...
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First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever chest pain I took Ibuprofen to relive the pain the next morning I had to see the doctor because I had sever pain but not related to the heart .
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| 43 | 2021-01-03 | increased heart rate, chest discomfort |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-03 | palpitations | Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint. |
| 43 | 2021-01-04 | palpitations, heart rate increased |
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo...
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About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | blood pressure increased |
Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 re...
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Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.
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| 43 | 2021-01-04 | palpitations | Dizziness, nausea, light headedness, palpitations |
| 43 | 2021-01-04 | heart rate increased |
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f...
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No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
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| 43 | 2021-01-04 | palpitations, blood pressure increased, heart rate increased |
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned...
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Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | hypertension, heart rate increased, pallor |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-05 | heart rate increased |
Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe...
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Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020. Follow-up attempts are not possible. No further information is expected.
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| 43 | 2021-01-06 | chest discomfort |
ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest ti...
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ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.
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| 43 | 2021-01-06 | fast heart rate | Immediate flushing of skin, tachycardia, impaired cognition |
| 43 | 2021-01-06 | palpitations |
heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a cont...
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heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self. A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa. the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event. The palpitations were resolving. The patient wasn't COVID tested post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-07 | fast heart rate, hypertension |
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac mo...
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Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
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| 43 | 2021-01-07 | fast heart rate |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-07 | hypotension | FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION |
| 43 | 2021-01-07 | chest discomfort |
I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am...
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I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?
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| 43 | 2021-01-07 | blood pressure increased, heart rate increased |
Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30...
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Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 43 | 2021-01-07 | hypertension |
RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of...
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RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.
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| 43 | 2021-01-07 | heart rate increased |
extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a sponta...
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extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest. Information on the lot/batch number has been requested.
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| 43 | 2021-01-07 | palpitations |
increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous re...
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increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital. Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.
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| 43 | 2021-01-08 | fibrin d dimer increased | Generalized edema, shortness of breath, change in taste |
| 43 | 2021-01-09 | chest discomfort |
Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later...
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Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.
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| 43 | 2021-01-09 | nosebleed |
fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. A...
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fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.
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| 43 | 2021-01-10 | chest pain |
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne...
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Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
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| 43 | 2021-01-10 | chest discomfort | Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol |
| 43 | 2021-01-11 | blood pressure increased |
Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and...
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Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip. Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72. She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink. She was observed for 30 minutes and symptoms gradually improved. Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61. She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication. She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist. She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed. She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours. She expressed understanding. She stated that she was comfortable going home and continuing to monitor her symptoms.
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| 43 | 2021-01-11 | fast heart rate |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-12 | chest pain, hypertension | HYPERtension chest pain (mild), anxiety |
| 43 | 2021-01-12 | chest pain, chest discomfort |
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs...
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I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
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| 43 | 2021-01-12 | palpitations |
Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at...
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Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at 8:23am and 5 minutes later she experienced palpitations. HR 150 -190. Sent to ED for evaluation at 8:37am. In ED, her HR was in the 90s and patient feeling better. BP 134/95. No further treatment. Patient discharged at 9:13am
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| 43 | 2021-01-12 | fast heart rate, fast heart rate |
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has ...
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Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Supraventricular tachycardia (pt has prior hx of this): ambulance to hospital. Pt assessed & released same day. Pt is free from that symptom now. Also experienced painful knot under arm lasting 5 days
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| 43 | 2021-01-13 | pallor |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | heart rate increased |
I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It to...
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I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down
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| 43 | 2021-01-13 | chest discomfort, palpitations |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | chest pain |
Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was exa...
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Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.
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| 43 | 2021-01-13 | chest discomfort |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | heart rate irregular | fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent |
| 43 | 2021-01-14 | fast heart rate |
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ...
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5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
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| 43 | 2021-01-14 | deep vein blood clot |
Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on...
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Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
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| 43 | 2021-01-14 | hypertension |
On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenop...
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On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.
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| 43 | 2021-01-14 | chest discomfort |
Patient experienced chest tightness after her first COVID vaccine dose. Pt reported similar reactio...
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Patient experienced chest tightness after her first COVID vaccine dose. Pt reported similar reactions to vaccines in the past.
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| 43 | 2021-01-14 | palpitations |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-14 | chest discomfort |
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | chest discomfort |
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-15 | blood pressure increased |
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int...
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Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
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| 43 | 2021-01-16 | chest pain |
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m...
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Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
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| 43 | 2021-01-17 | nosebleed |
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon...
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Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-01-17 | heart rate increased, palpitations |
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and...
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Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
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| 43 | 2021-01-17 | hypertension, fast heart rate |
Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachyc...
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Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.
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| 43 | 2021-01-17 | chest discomfort, palpitations, chest pain |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-18 | cerebrovascular accident |
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy...
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Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
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| 43 | 2021-01-18 | palpitations, chest discomfort |
Palpitations and mild chest discomfort Palpitations have been intermittent throughout the day but o...
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Palpitations and mild chest discomfort Palpitations have been intermittent throughout the day but occur all day long - few beats stop and then recur Some midsternal chest discomfort non radiating at rest The only change that would have occurred is the vaccine
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| 43 | 2021-01-19 | chest discomfort |
Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after s...
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Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.
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| 43 | 2021-01-19 | blood pressure increased |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | fast heart rate | Systemic: Tachycardia diagnosed by physician |
| 43 | 2021-01-19 | chest discomfort |
approximately 12 hours after vaccine was administered, patient experienced the following symptoms: s...
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approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.
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| 43 | 2021-01-19 | lightheadedness, heart rate increased |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-20 | chest pain | Chest pain, muscle pain, left arm soreness, fatigue |
| 43 | 2021-01-21 | heart rate increased |
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i...
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20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
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| 43 | 2021-01-21 | fast heart rate |
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizzine...
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About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.
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| 43 | 2021-01-21 | chest discomfort |
Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccin...
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Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.
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| 43 | 2021-01-21 | blood pressure increased | ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS. |
| 43 | 2021-01-21 | heart rate increased, chest pain, pallor | Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy. |
| 43 | 2021-01-21 | pallor |
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal...
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Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
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| 43 | 2021-01-22 | chest discomfort |
Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms laste...
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Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms lasted for 4 hours. Patient did not feel short of breath or pain, just chest tightness to the point of irritation
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| 43 | 2021-01-22 | chest discomfort, palpitations, lightheadedness |
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m...
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Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
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| 43 | 2021-01-24 | fainting, loss of consciousness |
COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of co...
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COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-24 | haemoglobin decreased, palpitations, heart flutter |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | heart rate increased, blood pressure increased, fast heart rate |
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b...
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Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
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| 43 | 2021-01-24 | palpitations |
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, ...
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Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
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| 43 | 2021-01-25 | chest pain |
As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain ...
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As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to Palms of Pasadena hospital with non-urgent acuity.
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| 43 | 2021-01-25 | chest pain |
As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest...
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As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest pain on deep inspiration. Initially became short of breath, which resolved prior to EMS arrival. EMS transported patient to the emergency room with non-urgent acuity.
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| 43 | 2021-01-25 | chest pain |
Immediately following vaccination, the patient reported her left arm "becoming heavy", then she beca...
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Immediately following vaccination, the patient reported her left arm "becoming heavy", then she became dizzy with chest pain on deep inspiration. EMS transported patient to hospital under non-urgent acuity. Primary impression was generalized anxiety consistent with PMHx of anxiety episodes.
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| 43 | 2021-01-25 | chest discomfort |
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir...
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chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
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| 43 | 2021-01-26 | heart rate increased, blood pressure increased |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | nosebleed |
I had a prolonged nosebleed. i could not get it to stop for 20 minutes, i held my nose, took a showe...
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I had a prolonged nosebleed. i could not get it to stop for 20 minutes, i held my nose, took a shower. I have not had a nose bleed in years. I was so strange. Even when i was younger it would typically stop after 1-2 minutes. but this was just a prolonged bleed. I was concerned that my platelets were low and making an appointment to get them checked. As i read information about ITP but i wanted to insert this as a possible vaccine VAERS in case others experiences a similar manifestation after the vaccine
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| 43 | 2021-01-26 | heart rate increased |
I received my first vaccine on Dec 18. By Dec 25, I had already started with rapid weight loss and a...
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I received my first vaccine on Dec 18. By Dec 25, I had already started with rapid weight loss and a feeling of increased energy/metabolism with a fast heart rate. Over the next week, the symptoms escalated and my heartrate was consistently in the range of 95-125. I was losing 2lbs a day without any change in my diet. I lost 12lbs over 2 weeks as I tried to compensate and eat more. I had my thyroid checked with the concern of possible thyroiditis, but my TSH was well within normal limits. My FT3 was on the high end of normal but still within normal limits. Over this time frame, I am also having significant difficulty sleeping and only sleep for 3-5 hours most days. After my second vaccine on Jan 10th, my heartrate and weightloss stabilized and consistently still experiencing a heartrate around 100. I usually weigh around 120 lbs +/- 2 pounds and my weight is now consistently 110 +/- 2 lbs. I am an ER doctor, just for background reference of my medical knowledge. I had the nurse do an ECG on me at work and there were no concerning disruptions in the electrical conduction system of the heart. My blood pressure has been normal throughout, and sometimes rather high up to 160/110. My usual vital signs are BP 110/60 and HR 60-70.
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| 43 | 2021-01-26 | fast heart rate |
extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneo...
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extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-26 | palpitations |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-27 | fast heart rate, hypertension, palpitations | Dizzy, palpitations, tachycardia, high blood pressure |
| 43 | 2021-01-27 | lightheadedness, palpitations |
Received vaccine at 14:30H at work. Was monitored for 15 minutes. Felt fine. Went back to work as a...
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Received vaccine at 14:30H at work. Was monitored for 15 minutes. Felt fine. Went back to work as a nurse on the same hospital where vaccine was administered. At 15:50H felt light headed, dizzy, palpitations, near syncope. Blood pressure 150/101, Hr 103. Was taken to the emergency room. Observed for 1 hr. Then discharged home.
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| 43 | 2021-01-27 | chest pain |
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ...
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intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
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| 43 | 2021-01-28 | chest pain, chest discomfort |
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ...
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Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
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| 43 | 2021-01-28 | chest pain |
Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to t...
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Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.
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| 43 | 2021-01-29 | chest discomfort |
Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequenc...
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Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection
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| 43 | 2021-01-29 | chest pain |
cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to ...
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cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
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| 43 | 2021-01-31 | chest discomfort |
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t...
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01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
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| 43 | 2021-01-31 | chest discomfort |
dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe ...
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dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
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| 43 | 2021-02-01 | palpitations |
20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathi...
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20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathing and constriction in throat. Vitals stable, pulse ox 100%, pharynx clear without edema and no wheezing. However she was quite distressed, becoming diphoretic, and stating that breathing and throat constriction was worsening. She was treated with 0.3 mg epinephrine IM left thigh and 25mg Benadryl left deltoid. After treatment breathing improved, throat constriction resolved, and she felt a rapid heart rate and dizziness. These also gradually improved and she was discharge home with her husband, with prescriptions for famotidine, loratadine, to not take metformin today, and strict ED precautions for recurrence of breathing or throat constriction symptoms.
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| 43 | 2021-02-01 | hypertension, heart rate increased | Racing pulse and High blood pressure |
| 43 | 2021-02-02 | palpitations | Dizziness, heart palpitations |
| 43 | 2021-02-02 | chest discomfort | Hives, Rash, itching, chest tightness, throat tightness, dry mouth, difficulty breathing |
| 43 | 2021-02-02 | chest pain |
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sid...
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I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
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| 43 | 2021-02-02 | fast heart rate, hypertension, palpitations |
Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest...
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Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest & back up to the scalp. Taken straight to the ED, evaluated by MD, found to be very anxious & hypertensive (BP 203/128, P 110). Treated with IV Benadryl & Pepcid.
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| 43 | 2021-02-02 | heart rate increased, palpitations, fast heart rate, fibrin d dimer increased |
Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's....
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Patient developed tachycardia at 0600 on 2/2/21 and reported to the ED with heart rate in the 190's. ED notes as follows. Discharged in stable condition with a Holter monitor. Initial Vital Signs [02/02/21 0713] Blood Pressure 139/93 Heart Rate 126 Respiratory Rate 18 Temp 37.2 °C (98.9 °F) Temp src Oral SpO2 99 % 43 y.o. female who arrived to the emergency department for Palpitations and tachycardia. Patient states that the symptoms started approximately 545 this morning while getting ready for work. She states that palpitations started spontaneously with no inciting event. She denies chest pain or shortness of breath. She states that she felt the palpitations and looked down to her watch and showed a heart rate into the 190s to 220s. Upon arrival to the emergency department her heart rate is in the 190s. When she was brought back to the room, her heart rate was around 120-130. Still denying any chest pain or shortness of breath. She did receive her second for Covid vaccine yesterday. No reaction with the first vaccine. No changes in medication, caffeine intake. Denies smoking, drinking, drug use. No history of similar events. Father has a history of a heart block requiring pacemaker. Medical history of melanoma varicose veins but no cardiac or pulmonary history including pulmonary embolism.Patient is a nurse in the neurosurgical unit as one of the case managers During initial evaluation, patient was sitting in bed in no acute distress. Vitals signs stable tachycardia although better than initially arriving. Physical exam unremarkable. Labs indicate elevated D-dimer. We will proceed with CT PE. CT scan of scan shows no signs of PE there is evidence of left axillary adenopathy which is consistent with her vaccination yesterday. Upon repeat evaluation, patient was updated regarding lab and imaging results. Heart rate had improved greatly down to the 90s to low 100s. She was able to ambulate around without becoming grossly tachycardic, dizzy, lightheaded or shortness of breath. Unsure of exact cause of palpitations and tachycardia. Recommend outpatient monitoring with Holter monitor. Follow-up with primary care provider or cardiologist. Return to emergency department if symptoms return or new concerning symptoms occur. Treatment plan was discussed with the patient who was agreeable and exhibited understanding. Questions were answered to patient's satisfaction. Through shared decision making with the patient and the emergency medicine care team, we discussed and decided the patient is stable and ready for discharge. Patient remained hemodynamically stable in the emergency department. Patient was provided with verbal and written follow-up/discharge instructions and return precautions. Recommend follow up with PCP in 2-3 days for symptom re-evaluation and further management. Patient should return to emergency department if symptoms worsen or new concerning symptoms develop.
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| 43 | 2021-02-02 | hypertension, heart rate increased, blood pressure increased |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-03 | blood pressure increased |
Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringi...
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Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.
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| 43 | 2021-02-03 | fast heart rate, chest discomfort |
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd...
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Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
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| 43 | 2021-02-03 | chest pain |
fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain...
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fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit. Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.
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| 43 | 2021-02-04 | excessive bleeding |
I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware o...
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I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.
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| 43 | 2021-02-05 | heart rate increased | RAPID HEART RATE |
| 43 | 2021-02-07 | blood pressure increased |
Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:9...
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Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92
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| 43 | 2021-02-09 | low blood oxigenation |
Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing....
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Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing. Progressed to difficulty breathing/shortness of air and unclear thinking. Related hypoxia occurred. Treated at home with antihistamines and albuterol. Epi-pen was not used, but should have been.
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| 43 | 2021-02-09 | hypertension |
Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist....
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Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
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| 43 | 2021-02-09 | vaginal haemorrhage |
I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregn...
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I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregnancy with no complications. I'm in healthcare and in the operating often for airway and ENT procedures. I received my shot at 9:00am on 1/29/20201 and began spotting at 11:00am. The spotting continued (very light) until 9:00pm. I decided to go to bed since I wasn't feeling well. I woke at 2:00am with contractions and heavy bleeding. I went to the ED at 3:00am on 1/30 to confirm my miscarriage. I weighed 121 at the ED when triaged. My EDD was 08/19/2021
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| 43 | 2021-02-10 | lightheadedness | Presyncope 15 min post vaccination |
| 43 | 2021-02-10 | fast heart rate |
Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat...
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Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours. She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.
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| 43 | 2021-02-10 | chest pain | chest pain, joint pain, body pain |
| 43 | 2021-02-10 | chest pain, hypertension | chest pains, body aches, high blood pressure |
| 43 | 2021-02-14 | chest discomfort |
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe...
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Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
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| 43 | 2021-02-15 | chest discomfort |
Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl...
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Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl and monitored for 30 minutes and was better after administration of the benadryl
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| 43 | 2021-02-15 | fainting | fainted after injection |
| 43 | 2021-02-18 | loss of consciousness |
A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I h...
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A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I had a head contusion and consuccion resulting in a few stitches in my head. Several test were ran but all were normal.
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| 43 | 2021-02-18 | chest pain |
I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I r...
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I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I received the first vaccine on 2/14/21 around 4:55 pm. 2/15-I awoke at 7am: sweating, headache, body aches/ pinging type sensation, fatigue, pain across my chest , no trouble breathing though. These are the same symptoms I had when I had Covid. 2/16 I was able to get out of bed, run errands, but still have headache, still feel achy, haven?t noticed a fever but I have had moments of sweating like one broke. Lymph nodes under my left arm are swollen and painful to touch. 2/17lymph nodes still very large and swollen, pings of 2/18: fatigue, weakness, 11pm- right arm became cold and numb like it was asleep, pinging muscle aches or more accurately pains where lymph nodes are located. Body seemed swollen overall too. 2/19: right arm and uncle still swollen and heavy Groin lymph area right side is painful today.
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| 43 | 2021-02-19 | vaginal haemorrhage |
8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,...
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8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.
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| 43 | 2021-02-19 | fast heart rate | Tachycardia, agitation, hive on site of injection, |
| 43 | 2021-02-21 | vaginal haemorrhage |
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on...
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On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
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| 43 | 2021-02-21 | chest discomfort |
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res...
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Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
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| 43 | 2021-02-22 | blood pressure decreased |
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping....
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Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
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| 43 | 2021-02-22 | palpitations |
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt ...
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pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
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| 43 | 2021-02-23 | fast heart rate |
"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination...
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"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache
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| 43 | 2021-02-23 | chest discomfort, fast heart rate |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-23 | chest discomfort | Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe |
| 43 | 2021-02-24 | hypotension |
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc...
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A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
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| 43 | 2021-02-24 | chest pain, fast heart rate, chest discomfort |
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv...
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Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
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| 43 | 2021-02-25 | chest pain |
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon...
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Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
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| 43 | 2021-02-26 | vaginal haemorrhage |
Received 1st vaccine at 3weeks, 2nd vaccine at 6 weeks, at 7 weeks saw baby and heart beat at 9 w5 d...
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Received 1st vaccine at 3weeks, 2nd vaccine at 6 weeks, at 7 weeks saw baby and heart beat at 9 w5 d, started to spot and imaging showed no heart activity and baby stopped growing at 8w4d. D&C completed on 2/21 at 9w6d. No side effects from first vaccine, 2nd vaccine, body aches, fever (101) controlled with Tylenol, chills, joint pain, headache. Resolved after 3 days.
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| 43 | 2021-02-28 | fast heart rate | 10 minutes after vaccine pt developed sob, tachycardia, vomiting - taken to ED |
| 43 | 2021-02-28 | lightheadedness, arrhythmia |
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have...
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she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-03-01 | chest discomfort |
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E...
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Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
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| 43 | 2021-03-01 | heart rate increased |
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep...
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heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
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| 43 | 2021-03-03 | blood pressure decreased, chest discomfort, heart rate increased |
10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tal...
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10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tall building, then quick pulses, and then I felt my lungs were full/heavy.
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| 43 | 2021-03-03 | fast heart rate, chest discomfort |
Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed...
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Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed lightheadedness. She was transferred to a litter and had a pulse ox applied. She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported). Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution. EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.
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| 43 | 2021-03-04 | chest pain |
11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started ...
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11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started hurting with a lot of chest pain. The pain started going behind my back and pressure and we went to ER and when I went to take my urine test and I threw up a lot. I felt pretty good after that. My reports from tests came back okay. They told me to take over the counter Prilosec and gave a prescription for Zofran.
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| 43 | 2021-03-04 | heart rate increased |
Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest...
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Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest pain, unlabored breathing. Pt reports no allergies to vaccines, denies throat irritation, denies nausea. Pt escorted by EMT outside at 1455. Pt advised to wait an extra 15 minutes. Pt symptoms resolved. Pt left facility at 1530 with her son.
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| 43 | 2021-03-08 | chest discomfort | nausea, lightheaded, sensation in chest |
| 43 | 2021-03-09 | palpitations |
Client reported feeling heart palpitations during the post vaccination observation period. Client ev...
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Client reported feeling heart palpitations during the post vaccination observation period. Client evaluated by onsite EMS, who brought the patient to the observation area. Client denied chest pain or shortness of breath. Vitals 137/72, HR 94, SpO2 96% on RA. 12 lead ECG performed. Onsite EMS consulted with ER physician who reviewed ECG. Physician noted no acute changes on ECG. ED physician did not recommend transport or ED evaluation, and instructed the patient to follow up with her primary care physician. Client agreed to plan and was cleared to leave the observation area.
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| 43 | 2021-03-09 | chest pain | Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness |
| 43 | 2021-03-09 | hypotension |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
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| 43 | 2021-03-11 | blood pressure increased |
Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated ...
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Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated at 175/128, one minute late they checked again it was 184/109. Patient reported that heaviness on left side was getting worse. Nurse working the clinic got a wheelchair and took patient to Emergency Room. While they were on the way to the ER, patient started complaining of numbness and tingling down left side of arm.
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| 43 | 2021-03-11 | palpitations |
Three hours after the shot I began to feel extremely groggy, I went to lay down and I started heart ...
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Three hours after the shot I began to feel extremely groggy, I went to lay down and I started heart palpitations. It lasted about 2-3 hours. I was sleeping off and on so I'm not exactly sure of the duration. When I woke up at 6 am the next day, I felt fine.
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| 43 | 2021-03-12 | fast heart rate |
Tachycardia after the first dose and the dr gave her a monitor for heart rate, 20 mins after the sec...
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Tachycardia after the first dose and the dr gave her a monitor for heart rate, 20 mins after the second dosse her heart rate was 140.
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| 43 | 2021-03-14 | fibrin d dimer increased, pulmonary embolism, deep vein blood clot |
Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on...
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Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.
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| 43 | 2021-03-14 | palpitations |
sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other heal...
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sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 01Feb2021 13:45 at single dose for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 07:30, patient had sweating, palpitations, severe dizziness. The patient not received treatment for the event. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19.The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-03-15 | chest discomfort |
Notes Expand AllCollapse All Patient: ...
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Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
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| 43 | 2021-03-15 | heart rate increased |
signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving...
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signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving first dose. Two days after first dose: heart rate increased to 130's resting, systolic blood pressure increased to 140's resting, (usual heart rate 70's-90's, usual systolic blood pressure 110's-120's), dizziness, headaches, very weak, temperature up to 99F. Symptoms lasted about two days. One day after 2nd dose: temperature up to 99F, heart rate increased to 130's resting (lasted about an hour), systolic blood pressure to 140's resting (lasted about an hour), felt flushed in the face, headaches, weak, temperature up to 99F, no dizziness. Symptoms lasted about one day.
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| 43 | 2021-03-16 | hypertension, palpitations |
After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was...
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After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was so mild and it was more notable in retrospect. A week after the first injection developed vertigo for the first time in my life. This lasted about a week had mostly resolved when I got the second dose. Immediately upon receiving the second dose I felt faint. I went to the observation area and when the feeling got stronger, reported it. My blood pressure was taken and although I always have normal blood pressure, it was extremely high - 195/100. My heart was racing. I was observed for longer because of this, and was asked to lie down. The faint feeling and high blood pressure lasted 30 min, at which time it started to improve and was sent home. I persisted in having bouts of feeling faint (but never fainting) in the days and weeks following, joined with shortness of breath which started the second day after the second injection. I also had the normal fever, aches and pains for 4 days. It is now a month after the second injection, and while the faintness and vertigo are mostly gone, I have persistent shortness of breath. Prior to the vaccine I had an albuterol inhaler that I would use 1-5 times a year for allergies. Almost never used it. I began having to use it multiple times daily after the second dose of the vaccine. I am not on a steroid inhaler. I have never had shortness of breath like this before. I was examined at the doctors office, not much can be seen that is wrong. An allergist believes that I did not have an allergy because my blood pressure was high instead of low as in anaphylaxis.
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| 43 | 2021-03-16 | cardiac arrhythmia, very slow heart rate, heart rate abnormal |
Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and ...
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Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and vision was blurry"; nausea-began having dry heaves (had not eaten), CBG 123, HR bradycardic and erratic, developed pounding HA, EMT stated "throwing PVCs"; then went to ER in POV
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| 43 | 2021-03-16 | palpitations | Palpitations, hard to swallow. Patient has history of anxiety. BP 126/72. Resolved |
| 43 | 2021-03-16 | chest pain |
Patient received her first dose of the Pfizer vaccine today. About five minutes after injection, pa...
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Patient received her first dose of the Pfizer vaccine today. About five minutes after injection, patient developed shortness of breath and a burning chest pain. She was talking in complete sentences without any issues. She had no other symptoms. Call placed to 911. Her lungs were clear through out, her heart rate and rhythm was regular. See vitals below. A 20g IV was placed to her L AC and Benadryl 25 mg IVP, Solumedrol 125 mg IVP and Famotidine 20 mg IVP was given by the RN. Her shortness of breath improved, the burning to her chest persisted. EMS arrived at 0914 and she was transferred to the nearest hospital for further evaluation and treatment. Patient declined contacting any family members by the staff, she requested to call her husband herself. 03/17/21 0923 BP: (!) 162/70 Pulse: 110 Resp: 22 SpO2: 98%
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| 43 | 2021-03-17 | palpitations |
Pt. in observation line was feeling dizzy with palpations. Paramedics assessed pt. vital signs norm...
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Pt. in observation line was feeling dizzy with palpations. Paramedics assessed pt. vital signs normal. Once symptoms subsided pt. was released to leave.
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| 43 | 2021-03-18 | chest discomfort |
My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, ...
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My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, nausea, body aches, and heaviness in my chest began around 4:30 pm. Eye spasms stopped after taking ibuprofen but began again 7 hours later.
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| 43 | 2021-03-18 | heart rate increased |
Received the vaccine and waited 15 minutes. When it was time to go the patient got up and fell dizz...
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Received the vaccine and waited 15 minutes. When it was time to go the patient got up and fell dizzy, vertigo and heart starting beating really fast. I then called the pharmacist and he tried to check her pressure but was unable because there machine wasn?t working. He then said to wait a little longer, after waiting another 15 minutes they tried to check her pressure with a portable machine that was collected from the pharmacy aisle . Didn?t seem like they could use that on either so they called paramedics. The whole time the patient felt anxiety because of her heart beating. Paramedics took the patient to the ER where they checked her heart beats and it recorded 140bpm then was given fluids and later discharged. 2 days later patient returned to the ER for the same symptoms.
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| 43 | 2021-03-19 | chest pain | Pain in middle of chest from 3/18/2031 at 10:00pm until 3/19/2021 at 3:00am |
| 43 | 2021-03-19 | loss of consciousness |
Patient started feeling nausea and then lost consciousness during the waiting period after the vacci...
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Patient started feeling nausea and then lost consciousness during the waiting period after the vaccine was administered. EMS was called and a cold pack was applied to the patients forehead, vitals were checked and they were all in range. Patient then started to feel much better after the ems had come and was well enough to go home unassisted
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| 43 | 2021-03-20 | chest discomfort |
L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest t...
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L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest tightness "uncontrollable urge to belch" without other assoc. symptoms; 125/93 -- 95 -- 120/89 chest tightness much improved - conversing & cheerful.
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| 43 | 2021-03-21 | palpitations |
palpitations- was having them though prior to vaccination. More frequent and occurring in more situa...
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palpitations- was having them though prior to vaccination. More frequent and occurring in more situations after vaccination
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| 43 | 2021-03-22 | loss of consciousness |
After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 m...
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After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 minutes passed out. For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye. After receiving my second doses, I felt extremely tired and within 3 hours of receiving got shooting pain on left side of my face. I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021. This pain has been constant since receiving the second dose on March 8.
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| 43 | 2021-03-22 | hypertension, palpitations, heart rate increased, chest discomfort |
Extreme dizziness and a whirlwind feeling 10 minutes after injection. Slight dizziness and headache ...
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Extreme dizziness and a whirlwind feeling 10 minutes after injection. Slight dizziness and headache for 2 days following. Beginning Monday 3/1 - rapid heart rate, hard palpitations, extreme dizziness, nausea, high BP, squeezing feeling in left chest, shooting pain thru underside of left arm and across collar bone lasting thru 3/6.
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| 43 | 2021-03-22 | lightheadedness | Near syncope treated oral glucose and IV fluids. Transport to local ED. |
| 43 | 2021-03-22 | fast heart rate |
Tachycardia one day after second vaccination, along with the normal side effects of body aches, feve...
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Tachycardia one day after second vaccination, along with the normal side effects of body aches, fever, chills, ache at vaccination site, nausea, fatigue. After the first vaccination, infected kidney from a prior UTI that took place two weeks prior to the first vaccine.
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| 43 | 2021-03-23 | fainting |
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BU...
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Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BUT HER VITALS WERE NORMAL AND LAID HER FLAT ON FLOOR. ACCORDING TO HUSBAND, PT. HAD NEEDLE FEAR AND WHEN SHE GETS ANXIOUS USUALLY FAINTS OR DIZZY. AFTER 3 TO 4 MINUTES , WITH WATER AND GATORADE DRINK, PT. WAS FINE WITH NORMAL VITALS AND LEFT STORE WITH SPOUSE
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| 43 | 2021-03-23 | fainting | mildly faint, heavy, mild urticaria. Evaluated be EMS-Cleared |
| 43 | 2021-03-24 | fainting |
Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A...
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Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Dec2020 07:30 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies as wine. Concomitant medication included loratadine (CLARITIN [LORATADINE]) 10 mg, as needed, daily for unspecified indication. On 23Dec2020 07:45 patient experienced Paresthesia tip of RIGHT little finger within 10 minutes of vaccine. Tachy arrhythmia, loss of function in RIGHT little finger/hand, and syncope 45 minutes after vaccine while driving. Tachycardia, hypertension, generalized weakness, and severe fatigue walking upstairs (persistent and worsened over several days). Loss of function/sensation RIGHT arm and RIGHT leg 8 days after vaccination. Symptoms persisted and worsened. Diagnosed with Guillain Barre Syndrome and POTS at follow up on 19Jan2021. She still have persistent weakness/paresthesias/neuropathy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Dec2020. Seriousness criteria for all events was hospitalization.The events Guillan Barre syndrome and syncope were medically significant. Outcome of the event Guillain Barre Syndrome was recovering. Outcome of the other events was unknown.
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| 43 | 2021-03-24 | chest pain, heart rate increased |
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swel...
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Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
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| 43 | 2021-03-24 | chest pain |
Patient complained of chest pain , vitals signs taken at 1109 and medical emergency response team ca...
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Patient complained of chest pain , vitals signs taken at 1109 and medical emergency response team called at 1109. 3-81mg Baby ASA given at 11:10. Transported to ER 1120
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| 43 | 2021-03-24 | palpitations |
Pt has experienced a full body rash, not just one specific to injection site. Rash presents as raise...
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Pt has experienced a full body rash, not just one specific to injection site. Rash presents as raised red, itchy bumps covering arms, legs, and torso of body. Pt has also experienced a racing heart upon presenting to pharmacy with reaction; may or may not be related to vaccination.
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| 43 | 2021-03-25 | palpitations |
Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue withi...
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Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue within 45 minutes
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| 43 | 2021-03-25 | palpitations |
I?m having heart palpitations since my first injection. Pretty frequently. No other signs or sympt...
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I?m having heart palpitations since my first injection. Pretty frequently. No other signs or symptoms.
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| 43 | 2021-03-26 | chest pain |
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,...
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Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
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| 43 | 2021-03-26 | heart rate increased |
Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with...
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Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.
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| 43 | 2021-03-26 | hypotension, fainting |
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotens...
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Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Medium, Additional Details: Patient became unresponsive. We gave cold compress to help with this. Blood pressure was 76/46. This happened at 10:57 am. We ask if patient was a diabetic she said no. Follow up phone call was completed around 4:30pm but no response. VM was left for patient to call back with update.
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| 43 | 2021-03-27 | heart rate increased |
Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. ...
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Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. Took benadryl went away after 10 min
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| 43 | 2021-03-27 | pulse abnormal |
Patient seemed slightly apprehensive, but stable after 20 minute observation period following immuni...
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Patient seemed slightly apprehensive, but stable after 20 minute observation period following immunization with COVID19 vaccine at 6:55. Patient requested to leave the store to check her blood sugar in her car, but shortly returned after (approximately 5 minutes), feeling stuffy and reporting that she was experiencing shortness of breath/difficulty breathing to the front store manager. Patient appeared diaphoretic, tearful, and having trouble breathing. PharmD felt for patient's pulse; felt thready and hard to palpate. PharmD administered epinephrine 0.3 mg via Epic-Pen into patient's left thigh, laterally, at 6:03 pm. Patient still appeared unwell, though conscious and breathing - pulse was difficult to palpate. 911 dialed and EMTs arrived within 3 minutes and took patient to the nearest hospital. Patient's family was present and sharing medical history with EMTs.
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| 43 | 2021-03-27 | hypotension, fainting |
Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. ...
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Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. Took an hour to recover.
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| 43 | 2021-03-28 | heart flutter |
Minor heart flutter; This is a spontaneous report from a contactable consumer. A 43-year-old female...
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Minor heart flutter; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 10Mar2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies: sulpha drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced minor heart flutter on 10Mar2021 20:30. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 24Jan2021 (covid test type post vaccination Nasal Swab). The patient recovered from the event on an unspecified date in Mar2021. Information on batch/lot number has been requested.
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| 43 | 2021-03-30 | chest pain, chest discomfort |
Chest pain and pressure; Chest pain and pressure; Unable to gasp air and hard time breathing; This i...
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Chest pain and pressure; Chest pain and pressure; Unable to gasp air and hard time breathing; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medication included methotrexate from an unknown date at an unknown dose, for an unknown indication. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (Lot number unknown) on 03Feb2021 at 15:00 (at the age of 43-years-old) via an unspecified route of administration in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 04:00 the patient experienced chest pain and pressure, the patient was unable to gasp air and hard time breathing. The events were reported as non-serious. The patient did not receive treatment for the events. The clinical outcome of the events chest pain and pressure and unable to gasp air and hard time breathing was recovering. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 43 | 2021-03-30 | heart rate increased |
muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint ...
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muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
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| 43 | 2021-04-11 | increased heart rate, fast heart rate, hypertension | Anaphylaxis, acute respiratory distress, mild tongue edema |
| 43 | 2021-04-14 | cardiac arrest |
I got the shot on Friday then had a low grade fever on Saturday, was fine until Tuesday, 3/30, when ...
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I got the shot on Friday then had a low grade fever on Saturday, was fine until Tuesday, 3/30, when I had a cardiac arrest event and my heart stopped beating. I needed CPR to be revived.
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| 43 | 2021-04-15 | transient ischaemic attack |
Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischem...
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Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.
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| 43 | 2021-04-15 | transient ischaemic attack |
Was talking with husband and commented that I felt a wave of tired coming over me. Immediately follo...
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Was talking with husband and commented that I felt a wave of tired coming over me. Immediately following the statement I was having difficulties speaking, slurred speech, and my body felt weighted. This lasted 2 minutes. This experience happened two more times so we left for the ER. Another episode happened while checking in the ER and they responded as if I was having a stroke. A 5th episode happened while in the ER waiting for a room and a 6th time after admission in the room with a nurse. This last episode was at 1:00pm on 3/5/2021. I could feel each of these coming on.
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| 43 | 2021-04-16 | fast heart rate |
Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After abo...
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Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After about 40 minutes of these symptoms , received Benadryl 50 mg po, symptoms continued, tachycardia and tachypnea developed and worsened to near continuous cough, hoarseness/laryngitis, tachypnea, tachycardia, nausea, dry heaves, difficulty swallowing, trouble catching breath over next 30 minutes or so. Received solumedrol 125 mg IV, epinephrine im x2, Pepcid IV, racemic epinephrine neb, epinephrine gtt starting at 0.05 mcg/kg/min. After 2nd IM epinephrine, symptoms slightly improved. After approximately 1h on gtt, was able to be decreased to 0.02 mcg/kg/min and then turned off after another 30-60 min.
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| 43 | 2021-04-17 | coughing up blood |
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events. No follow-up attempts are needed. No further information is expected.
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| 43 | 2021-04-24 | excessive bleeding |
bleeding; have not had a period in four years, five days after my second shot and I am having terrib...
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bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn't received treatment for the events. The clinical outcome of the events not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-04-28 | heart rate decreased, fainting |
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pu...
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Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.
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| 43 | 2021-04-28 | loss of consciousness, palpitations |
almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a con...
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almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-04-30 | loss of consciousness, heart rate increased, chest discomfort |
headache; suddenly blacked out for a couple of seconds; suddenly dizzy; very bad nausea; very fast h...
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headache; suddenly blacked out for a couple of seconds; suddenly dizzy; very bad nausea; very fast heart beat; tightness in her chest to her heart like she is going to have a heart attack; tightness in her chest to her heart like she is going to have a heart attack; This is a spontaneous report from a contactable consumer reporting for herself. A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:40 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation . Medical history included ongoing depression, ongoing anxiety. There were no concomitant medications. The patient suddenly blacked out for a couple of seconds on 13Apr2021 16:40 with outcome of recovered on 13Apr2021 , suddenly dizzy on 13Apr2021 16:40 with outcome of recovered on 15Apr2021, very bad nausea on 13Apr2021 16:40 with outcome of recovered on 13Apr2021, very fast heart beat on 13Apr2021 16:40 with outcome of recovered on 13Apr2021, tightness in her chest to her heart like she is going to have a heart attack on 13Apr2021 16:40 with outcome of recovered on 13Apr2021, headache on 14Apr2021 with outcome of not recovered. The event loss of consciousness was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included heart rate: fast on 13Apr2021. Follow up information has been requested. Lot number was already received.
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| 43 | 2021-04-30 | blood clot, deep vein blood clot, cerebrovascular accident |
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top...
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problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
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| 43 | 2021-05-03 | chest discomfort, hypertension, chest pain |
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Headache-Medium,...
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Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Hyperventilation-Medium
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| 43 | 2021-05-06 | blood clot |
First shot 12/23, 2nd 1/12/21. A week after #2 my menstrual cycles (which have been clockwork all of...
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First shot 12/23, 2nd 1/12/21. A week after #2 my menstrual cycles (which have been clockwork all of my life-I have 4 children and track it monthly) became much more frequent and heavy with excessive clotting. I thought perhaps I was going though early menopause (44) but then realized correlation with vaccine. My mood changed, I feel sad all of the time, I am dreading recommendation of additional shots.
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| 43 | 2021-05-07 | excessive bleeding |
Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/...
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Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity. On 21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before. The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
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| 43 | 2021-05-10 | heart rate increased, hypertension, palpitations |
high blood pressure/blood pressure 167/93/Blood pressure 144/95; Racing pulse/pulse was 177/pulse wa...
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high blood pressure/blood pressure 167/93/Blood pressure 144/95; Racing pulse/pulse was 177/pulse was 163/Pulse 116/ rapid pulse; Her heart was pounding; she couldn't catch her breath; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8983, Expiration date: Unknown), via an unspecified route of administration in left arm on 01Feb2021 at 08:45 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history included mitral valve prolapse (diagnosed at the age of 18). No known allergies. Concomitant medication included medroxyprogesterone acetate (DEPO PROVERA) from an unspecified date in 2020 and ongoing, received in two weeks within the vaccination. She took a Depo Provera shot on Saturday 30Jan2021, but she has been on this medication for a year now since either Feb2020 or Mar2020. The lot number and expiration date was unknown, since she has discarded the packaging. She usually picks up the drug, and her neighbour was a nurse, she usually just gives her the injection, since COVID has started. The patient previously received flu vaccine on an unspecified date in 2020 for immunisation and experienced feeling bad, didn't feel good. The patient previously received flu vaccine on an unspecified date for immunisation and experienced thrown up, chills, fever, body was sensitive. Caller was queried she if she had had any issues with vaccine in the past, caller states that she takes the flu vaccine every year, her body was sensitive to the flu vaccine, this year she had no issue, but last year (on an unspecified date in 2020) after the flu vaccine she started feeling bad, didn't feel good, years before she has thrown up and had chills and fever. Her body must be sensitive. However she has never had the heart issues. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested with COVID-19 post vaccination. It was reported that, she was calling about the COVID-19 vaccine. She received the vaccine yesterday at 8:45 AM, then at 12:30 PM she began to have a rapid pulse and high blood pressure. She went to the ER because of her pulse and blood pressure. In the ER, she received an IV to calm the heart, she doesn't know what was in the IV. They did blood work and told her the blood work was fine, and the chest X-ray was fine. She went to a Cardiologist today, she does have a valve prolapse, but she has had no issues with that for many years. She states that her body had a weird response to the covid vaccine. Caller states that she need Pfizer to know what happened because it was real scary. She has her first dose on 01Feb2021 at 8:45 AM. The rapid pulse began while she was sitting at the computer working. Her heart was pounding on 01Feb2021, she couldn't catch her breath on 01Feb2021, and so she was a school teacher, so then she went to find the nurse, and even in that she was having trouble catching her breath to be able to even talk. The nurse took her into the office, and she put a pulse ox monitor on her finger. At 12:25 PM her pulse was 177, at 12:30 PM her pulse was 163 with blood pressure 167/93, at 12:40 PM pulse 116, blood pressure 144/95. The nurse then called the ambulance because it was alarming. Caller states that doesn't know what her readings were in the ambulance. She went to the ER at (institute name withheld) and they did an EKG, 2 of them. The regular ER doctor was not super helpful, he said that she was okay to take the second vaccine. Caller did not agree with him thinking that the 1st covid vaccine sent her to the ER. HCP: He was at (institute name withheld) Cardiology. He did an EKG today (on an unspecified date in Feb2021), she doesn't know results at the moment. He didn't say if it was normal or abnormal. They did an echocardiogram, she was also assuming nothing was alarming or she would have been told the results. He listened to the heart and said it sounded fine, there was nothing he could detect. She did have a rapid heart rate at the cardiologist office, both pulse and blood pressure were elevated. He said that she was going to do a stress test in a week, the doctor was also going to see what the blood work from the ER yesterday looks like, he would also check the thyroid. He told her that next week she would also wear a heart monitor. She was at the doctor's office today at 10:30 AM. Her biggest concern was which she talked to the cardiologist today about was the 2nd dose of the vaccine. She doesn't want a repeat of this event. The cardiologist said that she was supposed to get the second dose in 3 weeks, let's do testing and see where we stand. Her 2nd dose was scheduled for 22Feb2021. She was concerned this happened. She doesn't know what could be done. This was bizarre. In the ER, the doctor said this wouldn't be considered an allergic reaction. Caller wonders what this was considered then. The ER doctors thing was that this didn't happen in first 15 to 30 minutes of receiving the vaccine, and that would be considered an allergic reaction if it did. She wants to know if this was an allergic reaction. Enquired was this allergic reaction. The adverse events resulted in emergency room/department or urgent care. She has no results for the tests that were performed at the ER, she was just told the chest X-ray was normal and so was the blood work, but she doesn't know what the blood work involved. They were looking for blood clots at the ER. She was not admitted into the hospital, she was sent home the same day. She has had no positive COVID test prior to the vaccine. She also has had no symptoms, and therefore no reason to get tested either. On 01Feb2021, the patient underwent lab tests and procedure which included chest X-ray: Normal, pulse rapid: 177 (at 12:25 PM), pulse rapid: 163 (at 12:30 PM), blood pressure: 167/93 (at 12:30 PM), pulse rapid: 116 (at 12:40 PM), blood pressure: 144/95 (at 12:40 PM). On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included blood work: Unknown results (the doctor was also going to see what the blood work from the ER yesterday looks like. They were looking for blood clots at the ER), EKG: Unknown results, EKG: Unknown results, Echocardiogram: Unknown results. The patient was treated with IV for the adverse events. The outcome of the events she couldn't catch her breath, her heart was pounding was unknown and not recovered for the other events.
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| 44 | 2020-12-31 | fibrin d dimer increased |
Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and trop...
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Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and troponin normal, Covid swab negative, diagnosed with pleurisy
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| 44 | 2020-12-31 | palpitations, blood pressure increased |
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v...
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Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
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| 44 | 2021-01-02 | palpitations | Diaphoretic palms, palpitations, jitteriness. |
| 44 | 2021-01-03 | hypertension |
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a...
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12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
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| 44 | 2021-01-03 | hypertension |
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou...
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12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
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| 44 | 2021-01-03 | hypertension, fast heart rate, chest discomfort |
EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING A...
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EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING AND SYMPTOMS RESOLVED.
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| 44 | 2021-01-03 | chest pain, chest discomfort | Fever (102.5 - 103.9), Pulse - 118, O2 - 94, Stabbing chest pain, Mediastinum tightness |
| 44 | 2021-01-03 | chest discomfort | felt hot, prickly, right arm red. Later felt chest tightness |
| 44 | 2021-01-04 | hypertension, palpitations |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-05 | chest pain |
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w...
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15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
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| 44 | 2021-01-05 | chest pain |
developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfo...
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developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | fainting | increased frequency of known recurrent syncope |
| 44 | 2021-01-06 | heart rate increased | Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness. |
| 44 | 2021-01-07 | palpitations, chest discomfort |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | chest pain |
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5...
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Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
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| 44 | 2021-01-08 | chest discomfort |
On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a...
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On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
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| 44 | 2021-01-08 | loss of consciousness |
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic...
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Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
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| 44 | 2021-01-08 | fast heart rate |
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three...
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Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
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| 44 | 2021-01-10 | low platelet count, troponin increased, platelet count decreased, inflammation of the heart muscle, chest pain |
1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent che...
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1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
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| 44 | 2021-01-10 | chest discomfort, fast heart rate |
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of...
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Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
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| 44 | 2021-01-11 | heart rate increased |
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat...
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About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
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| 44 | 2021-01-11 | heart rate irregular | Flushing, irregular heart beat, redness on chest |
| 44 | 2021-01-11 | heart rate increased |
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i...
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I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
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| 44 | 2021-01-11 | chest discomfort, heart rate increased |
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult brea...
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Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
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| 44 | 2021-01-11 | palpitations | pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721. |
| 44 | 2021-01-12 | chest discomfort |
@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also re...
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@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well. Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.
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| 44 | 2021-01-12 | palpitations |
About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes ...
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About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations. Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.
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| 44 | 2021-01-12 | fainting, loss of consciousness | nausea, syncope, LOC, fatigue |
| 44 | 2021-01-13 | blood pressure increased, blood pressure decreased, palpitations |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | chest pain |
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),...
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Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
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| 44 | 2021-01-13 | heart rate increased, blood pressure increased |
Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went t...
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Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went to work, 3:30 had blood pressure checked 174/102 and pulse was 98. Took Tylenol. Not dizzy. Monday covid negative
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| 44 | 2021-01-14 | palpitations | 8 hours after injection Chest palpitations Nausea Vomiting Diarrhea Headache |
| 44 | 2021-01-14 | pallor |
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o...
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Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
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| 44 | 2021-01-14 | blood pressure increased, fast heart rate | Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia |
| 44 | 2021-01-14 | chest pain |
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm...
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feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
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| 44 | 2021-01-15 | chest discomfort, palpitations |
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada...
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About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
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| 44 | 2021-01-17 | heart rate increased |
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ...
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Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
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| 44 | 2021-01-18 | blood pressure increased |
Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever...
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Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever did not go below 102.9 with both motrin and Tylenol. Fever finally broke completely on 1/14 at 330am. At 300pm I spiked a fever at 104.6 within 5 minutes and had vigorous rigors and horrible lower back pain. I was at work in the hospital and turned blue as per other nurses and doctors. I was evaluated b/p 144/100 HR 130 lactate 4.9. I am 120lb and have never had a b/p higher then 120. After NS Tylenol 2 liters of Lactated ringers my fever was 103.3 and the rigors stopped. I never had elevated wbc and my covid they did in the ER was negative. I went home. For the next 24 hours I continues with intermittent fevers. The next day I began with runny nose and sneezing. Since then I am very congested with headaches all day relieved partially with Motrin but never fully relieved.
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| 44 | 2021-01-18 | chest pain, blood pressure increased |
I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/b...
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I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/back, increase blood pressure and chest pain. Pepcid, benadryl and prednisone were given to me in the ER and a liter of fluids. VAERS number Date Form Completed: 01/06/2021 Temporary VAERS E-Report No: 223935 So on the second dose, I premedicated the night before 8pmwith 20mg of prednisone, 10mg of claritin, and 40mg of pepcid. In the morning 9am I took 40 mg of pepcid, 20 mg of predisone and 30 minutes prior to second vaccine around 12pm, I took 25mg of benadryl. After vaccine , I had severe nausea at about 20 minutes (1240p), and increase blood pressure at about 30 to 40 minutes. 156/94 was my highest. I had fewer areas of itching and specks of rash and itching around my back than on the first dose that I took. If I did not premediate, I am sure I would have had a similar or worse reaction since I still had similar reaction but milder.
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| 44 | 2021-01-18 | heart rate increased | Rapid heart beat for three weeks. Takes medicine for anxiety. |
| 44 | 2021-01-18 | deep vein blood clot |
Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis no...
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Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now
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| 44 | 2021-01-18 | fast heart rate |
tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report f...
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tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.
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| 44 | 2021-01-20 | heart rate increased, increased heart rate, lightheadedness, hypertension |
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C...
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near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-21 | heart rate increased |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-21 | chest discomfort |
Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered fr...
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Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered from covid several months ago.
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| 44 | 2021-01-21 | palpitations | Palpitations |
| 44 | 2021-01-21 | fainting |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-21 | loss of consciousness | Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic. |
| 44 | 2021-01-21 | chest discomfort, hypertension, fast heart rate |
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c...
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Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
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| 44 | 2021-01-21 | chest pain |
woke up with left sided chest pain and thought she may be having an MI; Injection received in left a...
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woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-22 | chest discomfort, loss of consciousness |
10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies...
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10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies numbness/tingling, sore throat, throat swelling, hives or fever. SBPs around 150s (normally in the 90s). Feels like she is going to pass out. Symptoms resolved and pt discharged at 2325.
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| 44 | 2021-01-22 | hypertension, palpitations |
About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest,...
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About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.
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| 44 | 2021-01-22 | palpitations | Racing heart, dizzy, flushed face, headache |
| 44 | 2021-01-22 | chest discomfort | Tightness in chest, cough and shortness of breath |
| 44 | 2021-01-24 | lightheadedness | Lower extremity weakness, dysarthria, presyncope |
| 44 | 2021-01-25 | blood pressure increased |
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines...
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Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
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| 44 | 2021-01-25 | blood pressure increased |
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision....
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Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
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| 44 | 2021-01-25 | chest pain |
ED provider notes as follows: Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate ...
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ED provider notes as follows: Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate 82 Respiratory Rate 20 Temp 36.7 °C (98.1 °F) Temp src Oral SpO2 98 % 44 y.o. female who arrived to the emergency department for Episode of right mid anterior chest pain intermittently ongoing starting around 10 PM this evening. She has had similar episodes in the past thought to be related to her gallbladder. Tonight she took some Pepcid and Tylenol. She denies any shortness of breath, or persistent chest pain, states pain has resolved since arriving in the emergency room. She denies any recent fever however she was recently given the second vaccine dose for COVID, and is having myalgias and symptoms she believes are related to the vaccination. She is requesting a COVID test. Patient denies sore throat, cough or abdominal pain. At this time only symptoms or myalgias. She continues to have no symptoms, her workup is reassuring, low suspicion for severe significant pathology, however would have a low threshold to return to the ER if chest pain would return or any other symptoms were to arise. COVID test came back negative.
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| 44 | 2021-01-25 | heart rate increased |
Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximatel...
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Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximately 160-170s. Then about 40 hours after vaccination a rash developed. Previous history of viral rashes. Rash covered front and back of trunk took benadryl but lasted approximately 2 days. Lastly, on 1.25.2021, had a CT with contrast for another medical concern (not related) ended up having an allergic response to the contrast. Has had multiple CT over the years (greater than 10) has never had a reaction.
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| 44 | 2021-01-26 | chest discomfort |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | blood pressure increased, blood pressure decreased, heart rate increased |
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Vis...
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Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
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| 44 | 2021-01-26 | fast heart rate, chest discomfort |
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat...
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Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
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| 44 | 2021-01-27 | palpitations |
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ...
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40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
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| 44 | 2021-01-28 | blood pressure decreased | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | very slow heart rate, pallor, loss of consciousness, hypertension | Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out |
| 44 | 2021-01-28 | chest pain |
Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced ...
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Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination. A day after vaccine, reports multiple episodes of subjectively bloody diarrhea. An evaluation by GI showed now abnormal findings. Patient tested for COVID and was negative. Advised not to get second dose of vaccine.
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| 44 | 2021-01-28 | hypertension |
Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled ...
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Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.
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| 44 | 2021-01-30 | chest discomfort | chest tightness and shortness of breath |
| 44 | 2021-01-31 | chest discomfort |
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca...
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10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
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| 44 | 2021-01-31 | chest discomfort | CHEST TIGHTNESS , DIFFICULTY BREATHING AND SCRATCHY THROAT TREATED WITH STROIDS ,BENADRL AND EPI |
| 44 | 2021-01-31 | hypertension, fast heart rate |
Patient described arm pain at the site of injection soon after injection. Began to develop difficult...
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Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.
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| 44 | 2021-02-01 | chest discomfort |
Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough...
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Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.
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| 44 | 2021-02-02 | chest pain |
after the fist shot i felt a bit out of breath and i had a bit of achiness in between my shoulder bl...
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after the fist shot i felt a bit out of breath and i had a bit of achiness in between my shoulder blades which i didn't think anything of because of Christmas and all then after my 2nd shot i felt more out of breath and my chest and throat felt achy if i pressed down on it
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| 44 | 2021-02-03 | fainting |
Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle...
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Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.
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| 44 | 2021-02-03 | heart rate irregular |
I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat. They lasted approxim...
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I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat. They lasted approximately 36 hours.
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| 44 | 2021-02-04 | fainting |
15 min after vaccine administered patient stated she had a frontal headache radiating to her right s...
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15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
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| 44 | 2021-02-04 | chest pain |
It began with right arm soreness and progressed to aches and low grade fever within the first 24 hou...
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It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.
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| 44 | 2021-02-04 | palpitations, blood pressure increased, fast heart rate |
Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 ...
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Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 @11:55, BP 167/105 @12:03, BP 181/96 @12:24; O2 sat 99%. Transported to the ED. Spent 3 hours in the ED BP down to 130/ Then discharged home. No recurrent episodes. Does not have history of high blood pressure.
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| 44 | 2021-02-04 | pallor, hypotension |
low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feel...
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low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation. Medical history included panic attack. There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
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| 44 | 2021-02-04 | heart rate increased |
rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare profess...
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rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 20Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included allergies: artificial orange in food and anxiety. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for birth control. The patient previously took first dose of BNT162B2 for covid-19 immunization on an unspecified date; and ammonia and experienced allergies. The patient was not pregnant at the time of vaccination. On 20Jan2021 14:00, the patient experienced rapid heartbeat and severe anxiety. The patient didn't go to the hospital and just worked through it herself as she has anxiety anyway. This lasted for about 4 hours. The patient did not receive treatment for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 20Jan2021.
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| 44 | 2021-02-07 | blood pressure increased, heart rate increased |
Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client rep...
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Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client reports lasting about an hour, increased then plateaued and then decreased with taking Benadryl. Similar circumstances with first vaccination lasting approximately 1.5 hours. Increased heart rate and increase blood pressure during both circumstances.
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| 44 | 2021-02-07 | heart rate increased |
HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later...
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HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later hr 120; patient states she feels better and wanted to go home;
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| 44 | 2021-02-08 | heart rate increased | 2:50 pm EE increase heart rate per EE. Has HX of anxiety, felt better within 15 minutes. |
| 44 | 2021-02-09 | palpitations |
At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by...
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At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by EMS, BP 135/83, pulse 90, Report O2 sat 99%, pulse 92. Client states she is feeling better. EMS discharge client. Client left vaccine site at 9:10 am.
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| 44 | 2021-02-10 | palpitations, chest pain, fast heart rate |
Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitation...
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Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitations; tachycardia; Confusion; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the right arm on 12Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included arthritis, B12 deficiency and Allergies: Wasp venom. The patient previously received first dose of BNT162B2 on an 21Dec2020 for COVID-19 immunization (first dose, intramuscular, right arm). Concomitant medication included paracetamol (TYLENOL) and cyanocobalamin (B 12). On 12Jan2021 19:00 PM, the patient experienced severe myalgia, severe arthralgia, severe Headache, rigors, extreme fatigue, chest pain, palpitations, tachycardia. Confusion. Fatigue began approx 6 hours post injection. Other symptoms culminated at around 12 hours post injection. Severe symptoms lasted approx 24 hrs with moderate symptoms following for another 48 hours, followed by mild symptoms for another 12 hours. No treatment was received for the events. Events were reported as non-serious: did not result in death, not life-threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 44 | 2021-02-11 | fast heart rate, chest pain |
ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST...
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ASMA TARQUICARDIA,PAIN ON INJECTION SITE,HEADACHE,CHILLS,FEVER,SICKNESS,ALERGIC ACTIVE PAIN ON CHEST AND REFLUX 2 DAYS OF SINTOMES.
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| 44 | 2021-02-15 | palpitations |
Pt felt that heart was racing and some shortness of breath. @ 1328 HR 118, BP 132/98. Recheck @ 1...
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Pt felt that heart was racing and some shortness of breath. @ 1328 HR 118, BP 132/98. Recheck @ 1352 HR 75, BP 130/98, RR 24. Pt feels recovered after resting and feels alright to drive home.
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| 44 | 2021-02-18 | chest discomfort, blood pressure increased, palpitations |
Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, ...
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Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later; cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
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| 44 | 2021-02-18 | chest pain |
awoke on 2-17-2021 at approximately 11:55pm with SOB and chest pain-prior to these symptoms had body...
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awoke on 2-17-2021 at approximately 11:55pm with SOB and chest pain-prior to these symptoms had body aches, sore throat, fever (100.3-101), chills approximately 5 hours vaccination
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| 44 | 2021-02-19 | heart attack | Patient suffered a heart attack on 2/17/2021 |
| 44 | 2021-02-21 | palpitations |
Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slig...
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Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slight itch to throat. NP and RN on sight assessed patient and had her sit in reclining chair with some water. 50 mg of Benadryl were administered orally at 1630. By 1720 patient was feeling better and her husband came to pick her up
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| 44 | 2021-02-21 | loss of consciousness |
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwi...
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Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
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| 44 | 2021-02-22 | chest pain |
5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever...
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5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED
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| 44 | 2021-02-22 | cerebrovascular accident |
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th...
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Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 44 | 2021-02-23 | palpitations, pallor |
Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racin...
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Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racing.
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| 44 | 2021-02-23 | fast heart rate |
Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and ...
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Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and feet redness. Her endo specialist advised her to take Claritin gel caps for 3 days. The reaction lasted 2 days and was advised not to take the 2nd shot.
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| 44 | 2021-02-24 | chest discomfort |
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administratio...
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Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.
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| 44 | 2021-02-25 | blood pressure increased |
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening an...
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Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events.
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| 44 | 2021-02-26 | palpitations | Palpitations, flushing, dizziness, shaky, chills, evaluated by EMS-cleared |
| 44 | 2021-02-26 | blood pressure increased |
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther...
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The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
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| 44 | 2021-02-27 | chest pain, chest discomfort |
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ...
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Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
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| 44 | 2021-02-27 | heart rate increased |
First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallo...
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First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate. I was asked to lay on gurney which I refused. I sat in chair. Paramedics monitored for 45 minutes until everything returned to normal. Walked to car by paramedics. Mom needed to drive home I was unable to.
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| 44 | 2021-02-28 | hypertension, chest discomfort |
Chest tightness experienced accompanied by high blood pressure and light headedness which started on...
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Chest tightness experienced accompanied by high blood pressure and light headedness which started on 2/2/21 at around 1900. Visited urgent care on 2/3/21, EKG, cardiac enzymes, and CBC drawn. EKG read abnormal. Cardiology consult was suggested. Symptoms persisted until 2/7/21.
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| 44 | 2021-02-28 | chest pain, pulmonary embolism, chest discomfort, blood pressure increased |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | hypertension |
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton...
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Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
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| 44 | 2021-02-28 | pallor |
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the...
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Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
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| 44 | 2021-03-01 | palpitations |
I experienced palpitations, dizziness and I felt like I was having a panic attack within 5 minutes o...
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I experienced palpitations, dizziness and I felt like I was having a panic attack within 5 minutes of the vaccine. I took Adavan medication. The following day I felt extreme exhaustion and fatigue. I was unable to do my work because I was so tired and had brain fog. More importantly, panic, heart racing feeling that was concerning to me because I thought it was related due to my seizures. Had a consult to my PCP and neurologist and they are monitoring me due to my symptoms. This has happened to me three times. As far as my second dose I had no reaction to the vaccine.
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| 44 | 2021-03-02 | palpitations |
Impaired thinking, began about 2 hours after vaccination. It is still ongoing. Loss of appetite. Nau...
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Impaired thinking, began about 2 hours after vaccination. It is still ongoing. Loss of appetite. Nausea. Rapid heart palpitations. Went to ER three days after the vaccine. Was given fluids and sent home. Continue to feel disoriented and fatigued.
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| 44 | 2021-03-02 | fast heart rate, hypertension |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | hypertension, fast heart rate |
Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. ...
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Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.
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| 44 | 2021-03-02 | heart attack, chest pain, blood clot, troponin increased |
very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus form...
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very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks. Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received. The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-03-03 | chest discomfort |
Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inh...
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Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inhailers and asthma attack stopped.
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| 44 | 2021-03-05 | chest discomfort, chest pain |
During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was...
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During pt observation after receiving COVID-19 vaccine, pt complained of feeling as if her chest was feeling tight. RN requested on site MD to come over and evaluate. After several minutes of MD speaking with pt, pt stated she felt as if her chest tightening was getting worse and it was painful and that her throat was "feeling weird". MD stated to alert on site Medics and have them complete further evaluation. Medics completed their eval and had on site first responder request an ambulance to further evaluate pt. EMS arrived at 1028 and after completing their evaluation of pt, it was determined to take pt to the hospital for further evaluation. Pt significant other drove their personal vehicle home. Pt was transported via ambulance at 1045 in stable condition to the hospital.
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| 44 | 2021-03-07 | blood pressure increased, heart rate increased, chest pain |
After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I...
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After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.
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| 44 | 2021-03-07 | palpitations |
Pt drove up post vaccine to observation lot. Pt stated " I feel short of breath and heart racing". ...
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Pt drove up post vaccine to observation lot. Pt stated " I feel short of breath and heart racing". EMT(on site) was called, Hr-88, o2-97% RA. Respiratory rate WNL. Pt kept for observation for 30 minutes. Pt discharged at 3:50 pm. EMT follow up with patient before discharge.
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| 44 | 2021-03-08 | palpitations, chest pain |
1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea ...
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1/7/21-1/9/21: fevers consistent >39.5 x 36hrs 1/7/21- 1/8/21 extreme nausea and vomiting--nausea has continued daily, vomiting is decreased to 2-3 days/week. Zofran 8mg has been used as needed 2/8/21 ALT164, AST 156 (increased from post vaccine January '21) Aldolase 10.2, CK 199, Alk Phos and Bilirubin normal, WBC and neutrophil sudden decrease. UA 4+ bacteria epith cells and protein... worsening but negative culture 1/2021palpitations and chest pain intermittent but no respiratory distress Other Items: petechial rash to lower flank and extremities, facial rash, peripepheral edema, rash, and pain consistent with vascular inflammation. Right temporal lobe painful to touch. Neck pain. Throat pain and difficulty swallowing
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| 44 | 2021-03-08 | heart rate increased, palpitations, blood pressure increased |
patient received pfizer COVID19 vaccine and 10 minutes later complained of racing heartrate. checked...
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patient received pfizer COVID19 vaccine and 10 minutes later complained of racing heartrate. checked her blood pressure 147/102 HeartRate 117. Patient says she suffers from anxiety and was also feeling very anxious. no injection site reaction, no redness or swelling at injection site, no difficulty breathing. monitored patient and continued to check blood pressure. diastolic blood pressure and heartrate remained elevated last reading was 124/102 HR 108. Called her primary Dr who advised to monitor and have her come to office if blood pressure did not go down. Monitored her as instructed. HR and Diastolic BP was still elevated. Patient does suffer from high blood pressure as well as anxiety and after 1.5 hours went home to take her anxiety medication and continue to monitor her blood pressure at home and was instructed to go to doctor if blood pressure did not go down.
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| 44 | 2021-03-09 | heart rate increased |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-10 | palpitations |
Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart ra...
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Client is 12 weeks pregnant and has family history of cardiac issues. Client complained of "heart racing" and complaints of tingling of the tongue. No shortness of breath or distress. Vitals were taken twice. ECG monitor was placed due to family cardiac issues. ECG was normal sinus rhythm.
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| 44 | 2021-03-10 | lightheadedness |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | anaemia | Anemia |
| 44 | 2021-03-11 | chest discomfort |
Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard...
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Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard. I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice). The difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took my blood pressure, blood oxygen level, and listened to my lungs, heart, and throat. They said they sounded normal. After this, I waited at a parking lot for another 15-20 minutes. I felt a bit strange, but I could breathe better. They did not inject the EPI Pen.
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| 44 | 2021-03-11 | loss of consciousness |
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on...
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dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-11 | heart rate increased |
elevated heart rate pounding heart beat (could hear it) Pounding headache Turned red like a cherry w...
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elevated heart rate pounding heart beat (could hear it) Pounding headache Turned red like a cherry warm
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| 44 | 2021-03-12 | hypertension |
Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen...
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Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.
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| 44 | 2021-03-13 | vaginal haemorrhage | Extended Vaginal Bleeding |
| 44 | 2021-03-13 | chest pain |
Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of ...
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Felt very dizzy and chest started to hurt. I was very thirsty and my mouth felt like it was full of cotton. My lips swelled. This happened within a few minutes of getting the vaccine. I was already being observed in a 30 minute seat, 20-30 minutes were added and three different professionals addressed the issue including a nurse practitioner. About 20 minutes after leaving the facility, about 1.5-2 hours after getting the vaccine, I noticed I was easier to breathe and I hadn?t realized how much my tongue and inside of mouth had been swollen previously. After these 2 hours, I felt fine. The following day I experienced a headache and was tired. Otherwise was fine.
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| 44 | 2021-03-13 | blood clot |
Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday...
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Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday March 10, ordered ultrasound which was completed on Thursday March 11 and diagnosed a superficial blood clot. Prescribed Xarelto 10mg.
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| 44 | 2021-03-14 | heart rate increased |
Pfizer-BioNTech COVID-19 Vaccine EUA I experienced fast heartbeat in 40 mins after receiving the fi...
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Pfizer-BioNTech COVID-19 Vaccine EUA I experienced fast heartbeat in 40 mins after receiving the first shot. Since i was driving, pulled over and called paramedics. Heart rate returned to normal eventually.
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| 44 | 2021-03-16 | chest pain |
High fever, extreme fatigue, slept over 30 hours, chest pains, chills, no energy, sore throat, both ...
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High fever, extreme fatigue, slept over 30 hours, chest pains, chills, no energy, sore throat, both diarrhea and vomiting for about 24 hrs, excruciating headache for three days
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| 44 | 2021-03-17 | blood pressure decreased, heart rate increased |
Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and en...
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Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity. At which time it seemed to dry up what ever nasal mucus I had. Almost immediately I felt dizzy and light headed. Then came the my heart beating faster. My breathing quickened cold sweats began with the palms of my hands. This continued for about 3-4 minutes. When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes. I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection, other than the typical reported symptoms of sore arm, fatigue which I did experience, i felt like I was in a haze, similar to when you have a fever for 11 hours. And oddly, almost immediately the haze and fatigue lifted. No other adverse reactions after that.
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| 44 | 2021-03-17 | heart rate increased, chest pain, chest discomfort |
Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and abou...
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Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and about 15 minutes into my drive I began feeling very funny in my head, my heart rate went sky high, started shaking all over my body. Could barely drive called 911. Was advised to pull over and await for ambulance. Ended up at ER with elevated heart rate, chest pain and feeling winded. I could breath ok no swelling in throat but just felt like a elephant was on my chest
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| 44 | 2021-03-17 | blood pressure increased, chest discomfort, hypertension |
woke up feeling sweaty, headache, light headed, chest tightness. BP was 222/128, phoned MD who state...
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woke up feeling sweaty, headache, light headed, chest tightness. BP was 222/128, phoned MD who stated go to ER for hyper tensive crisis. Not sure if vaccine related but was told to report just in case.
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| 44 | 2021-03-18 | hypertension |
Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes afte...
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Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes after the injection. Blood pressure was taken repeatedly and high 150/100.
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| 44 | 2021-03-19 | chest discomfort |
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I a...
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Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT. I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked. I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
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| 44 | 2021-03-20 | fainting | Syncopal episode following vaccination |
| 44 | 2021-03-20 | vaginal haemorrhage |
Vaginal bleeding beginning immediately after first shot. 2 days after second shot vey heavy/hemorrha...
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Vaginal bleeding beginning immediately after first shot. 2 days after second shot vey heavy/hemorrhaging vaginal bleeding. Went to ER. Ultrasound & bloodwork all ok. Following up with gynecologist this week.
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| 44 | 2021-03-21 | pallor |
12 minutes after receiving the vaccine my throat started feeling tight. I waited 1 minute to make su...
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12 minutes after receiving the vaccine my throat started feeling tight. I waited 1 minute to make sure it wasn?t going to go away. I motioned for the security officer to come over so I could tell him my throat felt tight, I was dizzy and lightheaded. He called for a nurse. Several people came over to check on me, take my vitals, ask questions and administer an EpiPen. They noticed I was very pale. I felt better for about 1 min but symptoms came back. An ambulance was dispatched. They came and took vitals as well. I was then loaded into the ambulance and transported to the hospital. Vitals were again taken. I was monitored and blood was drawn. Blood work came back that I had low potassium so I was given an infusion of that. I was sent home with a script for Famotidine 20mg, Fexofenadine 180mg and Klor-Con M20. Around 7:45pm I felt my throat tightening again so I took the 2 meds for the allergic reaction. Throat still feels tight at 8:57pm but not as bad as it did at 7:45pm.
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| 44 | 2021-03-21 | chest pain |
3/21/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/21/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Chest pain, she reports that she is asthmatic .but does not have her inhaler. Assessment : Time of assessment 1615pm Alert and oriented and Anxious. No visible respiratory issues, no wheezing or stridor heard. Actions taken: took to stretcher, 1615 VS taken at 1615 BP- 144/58. P 84, O2 98%, 1625 recheck VS- BP- 114/65, P-74, O2- 94%, lying on stretcher family in the room, she reports feeling better. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/21/2021 3:45 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 44 | 2021-03-21 | lightheadedness |
Patient received 2nd dose of Pfizer vaccine on 3.21.2021. 4 minutes after receiving the vaccine (120...
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Patient received 2nd dose of Pfizer vaccine on 3.21.2021. 4 minutes after receiving the vaccine (1200), the patient came to the nurses station stating, "I feel like I'm going to pass out." Patient seated and given cool rag. Patient proceeded to feel difficulty breathing and itchy throat. Patient given 1 dose of epipen at 1205. Patient tolerated well. Patient states she is breathing easier at 1208. 1211, Patient drinking water, feels better. Pain 0/10. EMS called and transported to ER. Patient diagnosed with "vasovagal reaction" in ER. Physician noted that the patient has a history of panic attacks and that this incident felt similar to the patient. Patient has no difficulty swallowing, no ShOB, and/or swelling. Patient fully recovered from the reaction by the time she arrived to the emergency department. Patient discharged home with no restrictions.
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| 44 | 2021-03-22 | chest discomfort |
10 min. after pt. received the vaccine she began to wheeze. She used her own Albuterol MDI. There wa...
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10 min. after pt. received the vaccine she began to wheeze. She used her own Albuterol MDI. There was no improvement. She repeated the MDI 5 min. later. Her chest got tighter and wheezing increased. Pt. taken to treatment room and 911 called . Pt. given 25mg Benadryl by MD who is on site at vaccine clinic. At 0955, pt. given 0.3ml epi. in right upper arm. At 9:57 pt administered 2 more puff of Albuterol. On exam: HR 92, BP 138/82. EMS arrived 10:10, IV access obtained, dexamethasone pushed, and albuterol neb started. On transfer BP 144/80, pulse 85 and o2 sat 100%. Pt. remained awake and alert. Wheezing improving on transport at 10:20. Notes provided by Dr.
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| 44 | 2021-03-22 | fainting |
After approximately 5 minutes my arm was tingling from the injection site to my fingers, I became n...
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After approximately 5 minutes my arm was tingling from the injection site to my fingers, I became nauseous and went to the brink of passing out. An ambulance was called and my blood pressure had dropped to 100/60. My blood sugar also dropped.
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| 44 | 2021-03-22 | chest pain |
Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. Abou...
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Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. About a week or so after, extreme fatigue and body weakness began and never stopped. Weakness/shakiness/tremorlike tingling body/arms/legs. It would come and go mainly in arms at first. Now it is constant all over body and it never goes away- 2 months. The muscle weakness is debilitating. First tingling/weakness/shakiness, followed by numbness in arms and legs, mainly right leg. Also arms started falling fully asleep and numb at night while sleeping. During day constant muscle and body weakness/tingling - is constant and almost unbearing. Feels like bugs are crawling under skin all over body, fatigue, numbness, (pins and needles come and go, very "elective" kind of surges through. Sometimes remains and fades). Newest symptom as of only a few days ago, pain in elbows, upper arms, knees, legs, shins, lower back, shoulders, back. Achy pain and burning pain. Pain is new, came before the Burning pain, which is the latest. I imagine these pains are my muscles dying. Muscle Atrophy per ER 3/21/21 visit.
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| 44 | 2021-03-23 | loss of consciousness |
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe...
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Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
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| 44 | 2021-03-23 | pallor |
Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130...
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Pt c/o throat closing and tongue swelling. Nurse was notified at 14:18. EMS activated by EMT BP: 130/80. HR: 66. Pt appeared pale and gray. At 14:20. Epinephrine 0.3mg adm x 1 IM (L vastus Lateralis) by the RN. at 14:22, pt sts feeling better. At 14:25, pt sts throat feels as if closing and tongue swelling again. EMS has arrived at that time and pt agreed to be transported and they took over her care.
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| 44 | 2021-03-23 | chest discomfort, fast heart rate, palpitations, hypertension, chest pain |
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Hypertension-Medium, Systemic: Tachycar...
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Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient received Pfizer shot. After 15 minutes they developed a racing heart and \"chest warmness\". They went to healthcare provider and had a blood pressure of 170/60 in the right arm, 170/64 in the left arm, and a heart rate of 120. After 15 minutes the measurements were retaken, and the blood pressure decreased to 160/62 in the right arm and 150/60 in the left arm with a heart rate of 90. The patient had a history of high blood pressure and was on multiple medications for it.
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| 44 | 2021-03-24 | palpitations |
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous...
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Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
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| 44 | 2021-03-25 | blood pressure increased, chest discomfort, palpitations |
A few years ago I was innoculated against measles, mups, rubella, hepatitis, DTaP, Varicella and re...
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A few years ago I was innoculated against measles, mups, rubella, hepatitis, DTaP, Varicella and received the flu vaccine (required for medical program) I did not have any adverse reactions. No adverse reaction to the flu shot last year or in years past (can't recall the dates). After receiving my first Pfizer COVID vaccine dose on 3/25 I started having palpitations & chest tightness / discomfort around 12pm (about 2 hours after the shot). I went to Urgent Care and they gave me steroids & antihistamines which helped calm my system down. I was prescribed those same meds to take this week. Still experiencing some heart racing but it seems less frequent & not as severe today.
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| 44 | 2021-03-25 | chest discomfort, palpitations, blood pressure increased |
A few years ago I was innoculated against measles, mups, rubella, hepatitis, DTaP, Varicella and re...
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A few years ago I was innoculated against measles, mups, rubella, hepatitis, DTaP, Varicella and received the flu vaccine (required for medical program) I did not have any adverse reactions. No adverse reaction to the flu shot last year or in years past (can't recall the dates). After receiving my first Pfizer COVID vaccine dose on 3/25 I started having palpitations & chest tightness / discomfort around 12pm (about 2 hours after the shot). I went to the Urgent Care and they gave me steroids & antihistamines which helped calm my system down. I was prescribed those same meds to take this week. Still experiencing some heart racing but it seems less frequent & not as severe today.
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| 44 | 2021-03-25 | chest discomfort | Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm |
| 44 | 2021-03-25 | chest discomfort, palpitations |
I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had di...
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I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.
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| 44 | 2021-03-25 | palpitations |
right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointest...
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right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointestinal pain; dizziness; heart palpitations; This is a spontaneous report from a contactable Other HCP (the patient). This non-pregnant 44-year-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318 ), via an unspecified route of administration, in left arm on 20Feb2021 at 11:15 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included Grave's disease (treated with an ablation resulting in hypothyroidism). The patient had known allergies to raw egg whites, red food dye, and penicillin's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium (TIROSINT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN5318, on 30Jan2021, in the left arm COVID-19 immunization. On 20Feb2021, within 4 hours of receiving the vaccine at 4:15 PM, the patient experienced severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain. Starting at 48 hours after the vaccine she experienced dizziness, heart palpitations, and right sided facial twitching, No treatment was received. The clinical outcome of right sided facial twitching, severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain, dizziness, heart palpitations was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-03-26 | chest discomfort, heart rate increased |
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra...
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Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
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| 44 | 2021-03-26 | haemoglobin decreased, blood glucose increased |
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel...
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She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
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| 44 | 2021-03-26 | chest discomfort | chest warmth, rash |
| 44 | 2021-03-28 | fast heart rate |
3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she...
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3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.
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| 44 | 2021-04-01 | fast heart rate |
EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/lef...
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EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself). A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA). The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-06 | palpitations |
dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is...
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dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 18Dec2020 09:00 (at the age of 44-year-old) at single dose for COVID-19 immunization. Medical history included dairy allergy. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine nor any other medications the patient received within 2 weeks. Within five minutes of the immunization on 18Dec2020 the patient's heart was racing, she was dizzy, her throat started to swell, and she was brought to the ER where they gave her epinephrine and Benadryl. She was admitted to the hospital (Dec2020) two times within a week due to the same symptoms; continuous heart palpitations. She was still having heart palpitations. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. Since the vaccination, has the patient been tested for COVID-19. Covid test was negative on unspecified date. The outcome of the event heart was racing was not recovered and the outcome of the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events palpitations, dizziness and pharyngeal swelling occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-09 | heart rate increased, vaginal haemorrhage, anaemia, palpitations |
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple...
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About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
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| 44 | 2021-04-09 | fainting |
I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning...
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I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
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| 44 | 2021-04-09 | pulmonary embolism, cardio-respiratory arrest, blood clot |
Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney f...
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Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.
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| 44 | 2021-04-09 | low platelet count, inflammation of the heart muscle, chest pain |
nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report...
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nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 44 | 2021-04-12 | loss of consciousness |
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of c...
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Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
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| 44 | 2021-04-14 | chest discomfort |
Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/thro...
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Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
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| 44 | 2021-04-17 | blood clot, pulmonary embolism |
massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right V...
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massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine, colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date. Information about lot/batch number has been requested.
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| 44 | 2021-04-21 | nosebleed, loss of consciousness |
On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and lan...
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On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.
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| 44 | 2021-04-24 | fainting |
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star...
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PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-24 | nosebleed |
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eye...
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causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.
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| 44 | 2021-04-28 | hypotension, heart rate increased |
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal...
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I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
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| 44 | 2021-04-30 | chest discomfort |
It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture wi...
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It feels like an MS flare; left eye blood vessel rupture with pain; left eye blood vessel rupture with pain; pressure emanating to left eye; Dizziness; off-balance; headache and head pressure; headache and head pressure; chest heaviness; exhaustion; nausea; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 17:45 as single dose for COVID-19 immunization on an unspecified facility. Medical history included multiple sclerosis, ulcerative colitis, rheumatoid arthritis, and seasonal allergy from an unknown date. The patient took several unspecified concomitant medications taken within two weeks. The patient previously took metoclopramide (REGLAN) for nausea and experienced drug allergy. No other vaccines were taken in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 02Apr2021, the patient had MS flare, left eye blood vessel rupture with pain and pressure emanating to left eye, dizziness, off-balance, headache and head pressure, chest heaviness, exhaustion, and nausea. The patient visited the emergency room and physician's office where she was given an unspecified treatment. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-04-30 | loss of consciousness |
passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morni...
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passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morning of 05Apr2021; her hands and feet were cold; she was kind of sweating; she felt sick on 05Apr2021; her body temperature went up; her body felt warm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 04Apr2021 15:45 (3:45 PM) (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes Shellfish Allergy (Reported she has had a shellfish allergy for a long time, approximately 7-8 years). She said as long as she had no shellfish, she was completely fine. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). There was no additional vaccine administered on the same date as the COVID-19 Vaccine. The patient previously took bnt162b2 for COVID-19 immunization on 14Mar2021 first dose intramuscular at the left arm (Lot Number: EN6208). It was reported that the patient has received both doses of the Pfizer Covid 19 Vaccine. Her second Pfizer Covid vaccine was received on 04Apr2021. Caller started her menstrual cycle on 07Apr2021. She experienced abnormal vaginal bleeding that night. The following day on 08Apr2021 she passed out at work and was transported to the ER via ambulance. She was advised by the ER provider that her symptom was not related to the Covid 19 vaccine. However, she spoke with her OBGYN and was advised they have heard that abnormal bleeding maybe caused by the Covid 19 vaccine. The patient asked if symptom has been reported? It was further reported that she had her first COVID-19 Vaccine shot on 14Mar2021, and her second COVID-19 Vaccine dose on 04Apr2021 at 3:45 PM (PST). She clarified later in the day on 04Apr2021, the COVID-19 Vaccine kicked in. She said she felt sick on 05Apr2021. She said she felt uncomfortable on the morning of 05Apr2021, but still went to work. She said she felt OK once she got to work, but then took time off from work (on 05Apr2021) because she felt uncomfortable. She said when she got home from work (on 05Apr2021), she took 2 Tylenol. She said she was cold, and her body temperature went up, and she was kind of sweating. She clarified her hands and feet were cold, and later in the day (05Apr2021) her body temperature went up. She said she was aware of the COVID-19 side effects because some of her friends had similar symptoms, so she was kind of expecting the symptoms. She said later in the evening on 05Apr2021, she took 2 Advil and went to bed. She said her body felt warm, but she thought her symptoms were to be expected. She said on 07Apr2021, her (menstrual) period started at 10:00 PM. She said she had abnormal (more than usual) vaginal bleeding for the whole night. She said on 08Apr2021, she felt uncomfortable in the morning when she was getting ready for work. She said she went to work (on 08Apr2021), and at 1:30 PM passed out while at work. She said from her work, she was sent by ambulance to the Emergency Room. She said she was not sure if her passing out had anything to do with the COVID-19 Vaccine, but she had never passed out at work before. She said she asked the Emergency Room doctor about the COVID-19 Vaccine and her passing out. She said the Emergency Room doctor said her passing out had nothing to do with her second COVID-19 Vaccine dose. She said she read more online about the COVID-19 Vaccine. She said she then asked the nurse at her OBGYN's office about abnormal bleeding after getting the COVID-19 Vaccine. She said the nurse had heard of some cases of abnormal bleeding after getting the COVID-19 Vaccine. She said her OBGYN's nurse told her to call to find out if her abnormal bleeding had anything to do with her second COVID-19 Vaccine. She said her OBGYN's nurse provided her with the number to get more information about the COVID-19 Vaccine. It was added that while she was at the Emergency Room, she had 7 vials of blood taken, 2 ultrasounds; an external one of her tummy (abdominal ultrasound), and an internal one where something was stuck in her (transvaginal ultrasound). She said she did not know the results of her testing, and was waiting for a copy of her medical records. The patient also weighed 165 lbs on an unspecified date. It was reported that for the treatment she had taken 2 Tylenol and 2 Advil at different times while at home, but was at work, and didn't have the Tylenol or Advil to provide the dosing, NDC, Lot, and Expiration Dates. For the Emergency Room treatment she reported an EKG was done, and she was given an IV drip. She said she was not sure what IV fluids were given to her. The patient required visit to Emergency Room and stated she was taken by ambulance on 08Apr2021 and discharged from the Emergency Room at 6:00 PM the same day. The patient also visited Physician Office and stated she went for a follow-up with her OBGYN doctor at between 9:00 AM-10:00 AM on 09Apr2021. She said the Emergency Room doctor had called her OBGYN doctor on 08Apr2021, while she was in the Emergency Room. The patient underwent laboratory tests which includes: EKG, Blood Test, Abdominal Ultrasound, Transvaginal Ultrasound (All tests were performed while at the Emergency Room on 08Apr2021. Patient stated she was waiting for a copy of her medical records with the test results). The outcome of the events was recovered on Apr2021.
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| 44 | 2021-05-03 | heart rate irregular, arrhythmia |
had an arrhythmia; now she has an irregular heartbeat that sent her to the emergency room; This is a...
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had an arrhythmia; now she has an irregular heartbeat that sent her to the emergency room; This is a spontaneous report from a contactable consumer (patient). The reporter reported two reports for different dose for the same patient. This is the second of two reports. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 44-year-old via an unspecified route of administration on an unspecified date (Lot Number: EN6003; Expiration Date: Jun2021) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 for covid-19 immunisation and experienced a cough, she was tired and she had body chills; then she was struggling for 2 weeks maybe; then she went to the doctor and she had some kind of upper respiratory infection. The patient experienced an arrhythmia, and she had an irregular heartbeat that sent her to the emergency room. The events start date was 11Apr2021. She was admitted from the emergency room and was sent to be monitored for 24 hours and since then she has had episodes that happen once a week or so. It depends. She was just thinking maybe it was from the COVID vaccine because she has never had problems with her heart. Caller was admitted on 11Apr2021 and was discharged on 12Apr2021. The outcome was recovering.
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| 44 | 2021-05-04 | chest pain |
Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post va...
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Patient developed adverse reaction like fever, flu like symptoms and rashes on the first day post vaccine second dose (05/01/2021) and then she went to ER morning of 05/04/2021 at about 1 am due to chest pain and SOB
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| 44 | 2021-05-05 | palpitations |
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cra...
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Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
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| 44 | 2021-05-07 | loss of consciousness, palpitations |
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar...
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almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
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| 44 | 2021-05-11 | chest discomfort |
chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any a...
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chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any activity; breathing was difficult; difficult for his wife to talk and walk (because of her breathing).; difficult for his wife to talk and walk (because of her breathing).; allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband) A 44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), intramuscular, administered in Arm Left on 21Apr2021 at 13:30 (at the age of 44 years old)(Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes Dose 1 on 23Mar2021 administered left arm, Lot Number: ER8727 and Expiration Date: 01Jul2021 for covid-19 immunisation ('had no problem'). The patient medical history was not reported. Concomitant medication(s) included phenylephrine hcl (PHENYLEPHRINE HCL) CVS brand NDC Number: 59779-094-68, Lot Number: 0EE3081 Expiry: Jan2022, taken for nasal decongestion therapy from Apr2021 and ongoing.No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. On 22Apr2021, The patient experienced chest heaviness/very strong heaviness in her chest, restricted breathing, allergic reaction, difficult for his wife to talk and walk, more breathless with any activity, breathing was difficult. The patient underwent lab tests and procedures which included electrocardiogram normal: results normal on 24Apr2021. Therapeutic measures were taken as a result of chest heaviness/very strong heaviness in her chest, restricted breathing. The clinical course was reported as follows Husband Reported on behalf of his wife got her first COVID-19 Vaccine dose 1, and had no problem, and was fine. He said when his wife got her second COVID-19 Vaccine dose on Tuesday, 21Apr2021, the first day she was fine, but towards the second day (22Apr2021), she had a very strong heaviness in her chest, and her breathing was restricted. His wife thought she may be having a severe allergic reaction to the COVID-19 Vaccine. Reporter made a few calls to the doctor, and the doctor told him to continue to monitor his wife, and maybe in a day, or 2, her symptoms would go away. On Saturday, 24Apr2021, his wife still had the chest heaviness, and it was very difficult for his wife to talk and walk (because of her breathing). On Saturday, 24Apr2021, the patient went to an urgent care. The doctor (clarified as a PA-physician assistant) looked for other symptoms his wife might have, and told his wife she did not have the COVID-19 Virus. He said his wife was told there were reports that the Pfizer COVID-19 vaccine was known for thickening the blood and for causing inflammation of the heart, said that she had an allergic reaction so an EKG was done at the time, and the EKG was normal. The PA (physician assistant) prescribed Ibuprofen 600mg (Lot Number: DE2607, Expiration Date Feb2022) by mouth daily. Also reported as (' 3 Ibuprofen 200mg tablets a day (600mg total),', and told his wife to return in 3 days if her symptoms were not better. It was also Reported his wife's chest heaviness had gone away, but the came back. Chest heaviness was not worse, but it had not gone away. The caller stated the doctor (PA) concluded that the Pfizer COVID-19 Vaccine produced too many antibodies in his wife, and the antibodies made his wife's blood thick. He said the doctor (PA) prescribed the Ibuprofen to help with his wife's blood flow. Subsequently the patient's husband had called Pfizer to report his wife's experience, but to also to find out how long his wife needed to continue taking the Ibuprofen. Reporter's wife, entered the call. She said the doctor (PA) suggested the Ibuprofen for inflammation. She stated she was more breathless with any activity (if she spoke or moved around). She said if she sat still, her breathing was fine. She said she was not physically tired at all, but her breathing was difficult. She said her chest heaviness was OK yesterday (25Apr2021), but when she woke up this morning, she had the chest heaviness again. She said her chest heaviness was better, but persisting. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected
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| 44 | 2021-05-11 | deep vein blood clot |
unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-y...
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unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 15Apr2021 14:00 (Batch/Lot Number: ER873I) as 1st dose, single for covid-19 immunization. Medical history included Crohn's, HTN and ADHD. Concomitant medications included spironolactone and alfetamine aspartate, alfetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL).CHLORPERAZINE EDISYLATE]) and experienced allergies. The The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took prochlorperazine (COMPAZINE [PROpatient experienced unprovoked DVT of right lower leg on 23Apr2021 08:00. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of unprovoked DVT of right lower leg including Xarelto 15 mg bid. The outcome of the event was not recovered.; Sender's Comments: The reported deep vein thrombosis leg was more likely an intercurrent disease, and less likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 45 | 2021-01-02 | blood glucose increased, heart rate increased, blood pressure increased, palpitations |
After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pul...
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After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced
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| 45 | 2021-01-02 | lightheadedness |
Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable...
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Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.
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| 45 | 2021-01-03 | chest discomfort, chest pain |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-03 | hypertension, heart rate increased, chest pain |
High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is...
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High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-01-04 | heart rate increased | Severe dyspnea, wheezing, heart rate greater than 130 |
| 45 | 2021-01-04 | blood pressure increased |
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde...
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dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-01-05 | heart rate decreased, oxygen saturation decreased, very slow heart rate |
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine...
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Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
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| 45 | 2021-01-05 | chest discomfort |
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ...
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Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
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| 45 | 2021-01-05 | fast heart rate |
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms star...
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next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
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| 45 | 2021-01-06 | heart rate increased |
12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartb...
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12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.
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| 45 | 2021-01-06 | body temperature decreased |
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my...
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At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
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| 45 | 2021-01-06 | ischemic chest pain | Headache, Myalgia & Angina |
| 45 | 2021-01-06 | fainting, blood pressure increased, heart rate increased |
When patient initially received the vaccination, she complained of mild dizziness. She went home aft...
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When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.
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| 45 | 2021-01-06 | hypertension | around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak; |
| 45 | 2021-01-07 | palpitations |
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizz...
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06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
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| 45 | 2021-01-07 | blood pressure increased |
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ...
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After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
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| 45 | 2021-01-07 | chest discomfort | Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort |
| 45 | 2021-01-07 | chest pain, palpitations |
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati...
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I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
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| 45 | 2021-01-07 | fainting, blood pressure increased, blood pressure decreased |
PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ...
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PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.
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| 45 | 2021-01-07 | chest pain |
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started...
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Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
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| 45 | 2021-01-07 | fast heart rate, hypertension | Redness on face, neck, and arms, Tachycardia, HTN |
| 45 | 2021-01-07 | heart rate increased, chest discomfort |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
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| 45 | 2021-01-07 | chest discomfort, heart rate increased |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
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| 45 | 2021-01-08 | blood pressure increased, chest discomfort |
After 15 minutes patient reported chest pressure which increased with inspiration. could not report...
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After 15 minutes patient reported chest pressure which increased with inspiration. could not report rating on pain scale. Initial BP with complaints was 168/138. HR 88, RR 16, 98 o2sat, Temp 98.8. Follow BP 137/85 5 minutes later .Sent to ED at 12:53. 12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative. Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.
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| 45 | 2021-01-08 | lightheadedness |
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour...
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Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
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| 45 | 2021-01-09 | blood pressure increased |
1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and w...
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1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside. assessment repeated at 1840 B/P 136/94 HR 80, 1850 BP 140/100 HR 75 pt. reporting feeling better. Pt. reported feeling much better and left with friend at 1900.
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| 45 | 2021-01-10 | palpitations |
45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering,...
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45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved
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| 45 | 2021-01-10 | blood pressure increased, heart rate increased |
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di...
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Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
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| 45 | 2021-01-10 | heart rate decreased, fainting | Vasovagel syncope episode - passed out a total of 3 times Drop in pulse ox and heart rate |
| 45 | 2021-01-10 | lightheadedness, heart rate decreased | vasovagal episode drop in pulse ox drop in heart rate |
| 45 | 2021-01-11 | chest discomfort | Chest tightness, dizziness, chills. No reported treatment and symptoms resolved. |
| 45 | 2021-01-11 | palpitations |
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ...
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Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
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| 45 | 2021-01-11 | hypertension | Pt hypertensive response. BP 148/99, HR 109. |
| 45 | 2021-01-11 | heart rate increased |
Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her...
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Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her HR was also in 120's. At 1618, Epi given x1, then pt transferred to ED
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| 45 | 2021-01-11 | chest pain |
Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persis...
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Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persisting for 8+ hours until treated by cardiologist with addition of Flecainide. Flecainide 50 mg twice daily now part of medications.
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| 45 | 2021-01-12 | chest discomfort |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-12 | palpitations |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
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| 45 | 2021-01-12 | palpitations |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
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| 45 | 2021-01-12 | chest discomfort |
Pt reported chest tightness and throat tightness following vaccination. Time course following vaccin...
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Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.
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| 45 | 2021-01-12 | pallor, chest discomfort, palpitations |
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2...
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Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
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| 45 | 2021-01-12 | heart rate increased, fainting |
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 13...
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pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
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| 45 | 2021-01-13 | palpitations, chest discomfort |
15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palp...
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15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palpitations, lightheadedness and feeling faint. Patient's symptoms resolved by 4:15pm. Patient was prescribed Benadryl 50mg PO and PEPCID 40mg PO. Patient discharged from EC home at 6pm.
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| 45 | 2021-01-13 | chest pain |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | chest discomfort |
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then...
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After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
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| 45 | 2021-01-14 | heart rate increased, fast heart rate, blood pressure increased |
Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. ...
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Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. I then felt my heart rate increase. I took my heart rate from my apple watch and it was 145. Spoke to the nurse on site and she took my BP which was 185/140 (I am normally 120/80). Within a few minutes the heart rate started to drop but I was taken to the ED to be monitored. remained slightly tachicardic, but it was much better and BP dropped but was still elevated upon release -
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| 45 | 2021-01-14 | low platelet count |
COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia...
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COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3 Unclear if thrombocytopenia is from vaccination. No hx of this
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| 45 | 2021-01-14 | palpitations | High Palpitations for the day. |
| 45 | 2021-01-14 | palpitations |
Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 H...
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Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
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| 45 | 2021-01-14 | chest discomfort |
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel...
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wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
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| 45 | 2021-01-14 | chest discomfort | wheezing tight chest headache had to use a breathing treatment hot flush sensation |
| 45 | 2021-01-15 | palpitations |
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection...
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Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
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| 45 | 2021-01-16 | heart rate increased |
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivi...
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Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)
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| 45 | 2021-01-17 | fast heart rate | 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass |
| 45 | 2021-01-17 | palpitations |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-18 | fast heart rate |
Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but...
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Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.
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| 45 | 2021-01-18 | fast heart rate | Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia |
| 45 | 2021-01-18 | fainting |
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels...
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Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
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| 45 | 2021-01-19 | palpitations |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | hypertension |
Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nau...
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Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.
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| 45 | 2021-01-19 | palpitations |
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11...
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Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
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| 45 | 2021-01-19 | fast heart rate |
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine....
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pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
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| 45 | 2021-01-20 | chest pain |
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b...
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Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
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| 45 | 2021-01-20 | chest pain |
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl...
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Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
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| 45 | 2021-01-20 | chest pain, heart rate increased |
Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contacta...
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Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-24 | chest discomfort | HA/CP/Flushed/SOB/Dizziness after 20minutes-- > was taken to ER |
| 45 | 2021-01-24 | chest discomfort, chest discomfort |
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod...
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She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
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| 45 | 2021-01-25 | blood pressure increased |
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho...
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Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
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| 45 | 2021-01-25 | vaginal haemorrhage |
vaginal bleeding; This is a spontaneous report from a contactable nurse (patient) via Medical inform...
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vaginal bleeding; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm on 08Jan2021 at single dose for COVID-19 immunization. The patient have family history of diabetes mellitus from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took Vitamin B12 [cyanocobalamin] and experienced allergy rash and levothyroxine for hypothyroidism for more than a year. The patient received the first dose of the vaccine on 08Jan2021 at 11:20 or 11:25AM and at around 3 PM, she had noticed some vaginal bleeding. She thought it was her period but it stopped during the night (she mentioned she worked that night). She asked if this was a side effect from the vaccine. It was light, like when a person's period was coming but it was a brownish color, not red. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the event. The outcome of the event was recovered on 08Jan2021.
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| 45 | 2021-01-26 | chest pain |
Chest pains so bad I had to go to emergency room. Pain started 2 days after and another day to subs...
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Chest pains so bad I had to go to emergency room. Pain started 2 days after and another day to subside in chest. Arm that was injected took an additional 2 days to feel better.
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| 45 | 2021-01-26 | heart rate increased |
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei...
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Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
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| 45 | 2021-01-26 | fainting | Systemic: Exhaustion-Medium, Systemic: Fainting-Medium |
| 45 | 2021-01-26 | blood pressure increased, chest discomfort, palpitations, heart rate increased, pallor |
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p...
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intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | chest discomfort |
joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irrita...
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joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-27 | fast heart rate |
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad...
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5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
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| 45 | 2021-01-27 | fast heart rate |
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contacta...
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Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-01-27 | blood pressure increased |
Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevate...
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Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevated BP however patient noted that it was because she was anxious. Symptoms resolved within 30 minutes and patient left the clinic.
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| 45 | 2021-01-27 | heart rate increased, palpitations |
Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope w...
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Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope with previous blood donations received COVID-19 vaccine at 0645 and approximately 1 hour later developed a generalized feeling of warmth, followed by lightheadedness/dizziness. She denies frank LOC. She also reports palpitations and a rapid heart rate. She denied any rash, pruritis, dyspnea or chest pain, or N/V/D. Patient works in hospital and was transported to ED and upon arrival vitals were stable with HR of 79, BP 151/84, SaO2 of 100% on RA. Additional information for Item 18: Patient treated with IVF and released. Patient discharged to home and by 1:00pm that day was no longer symptomatic. She does endorse pre-syncope with previous blood draws.
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| 45 | 2021-01-28 | blood pressure increased |
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike...
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Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
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| 45 | 2021-01-28 | hypertension, oxygen saturation decreased | feeling of throat closing/HTN/drop in O2 sat, itchy throat dizziness |
| 45 | 2021-01-29 | heart rate increased, blood pressure increased |
About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated...
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About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated blood pressure and heart rate. Also felt slightly dizzy. Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing. Only treatment needed was vital sign monitoring. Vitals improved and no intervention was needed. I have had no further complications.
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| 45 | 2021-01-29 | blood pressure decreased |
Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour...
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Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.
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| 45 | 2021-01-29 | hypertension, fast heart rate | Tachycardia, high blood pressure, flushing Given Benadryl and observed in the ER |
| 45 | 2021-01-30 | blood pressure increased |
Patient felt faint after receiving the 1st dose of Pfizer, her blood pressure became elevated and sh...
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Patient felt faint after receiving the 1st dose of Pfizer, her blood pressure became elevated and she laid on the floor for approximately 30 minutes until she felt better.
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| 45 | 2021-01-31 | blood pressure decreased, palpitations |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
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| 45 | 2021-01-31 | hypertension, blood pressure decreased, palpitations, blood pressure increased, heart rate increased |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
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| 45 | 2021-01-31 | blood pressure increased |
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT...
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DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
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| 45 | 2021-01-31 | vaginal haemorrhage, haemoglobin decreased |
Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev...
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Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.
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| 45 | 2021-01-31 | nosebleed |
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol...
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Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
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| 45 | 2021-01-31 | heart rate increased, heart rate decreased |
heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional...
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heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional hour
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| 45 | 2021-01-31 | fainting | nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever |
| 45 | 2021-02-02 | hypotension, fainting |
Following day was hypotensive with blood pressure 70/65 and had syncope with fall and laceration to ...
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Following day was hypotensive with blood pressure 70/65 and had syncope with fall and laceration to face. Received CT scans, IV fluids in ER . Had another episode of syncope in ER. On days 2 severe pain abdomen with bloating, myalgia and fatigue that lasted fir 2-3 days.
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| 45 | 2021-02-02 | loss of consciousness |
Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for parame...
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Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for paramedics who took her blood pressure having 80/50, Patient recovered, felt better and didn't wanted to go to the hospital.
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| 45 | 2021-02-02 | chest pain, chest discomfort |
The day after the second shot, I developed upper right sided chest pain and pressure, lateral to the...
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The day after the second shot, I developed upper right sided chest pain and pressure, lateral to the sternum extending at times to mid-clavicular line. Sometimes it felt deeper than surface. I do have a scar from my port which was removed in 11/2020 and the location of the pain correlated at times with the scar but not consistently. I thought the pain was sore muscles since I had done some light weight exercises with my arms the morning of the vaccine. But the pressure aspect of it was different than sore muscles. And I could feel a localized pain when I swallowed or burped, like it was on the inside of my esophagus. The pain didn't seem to hurt with deep breaths. I thought it'd get better if it was related to muscles and the vaccine, but it just seemed to linger. I tried mylanta to test the esophagus theory and it improved. Then after a few more days of not resolving, I saw doctor. My biggest concern and fear at that visit was breast cancer recurrence. I was envisioning and enlarged node in my chest or lung. Eek! I had had a couple episodes at some point of painful swallowing prior to all this that I recalled in the visit so we opted to do an EGD. He also prescribed omeprazole which seemed to help. Had EGD done on 1-27-2020. Normal except for a loose GE junction which wasn't a surprise since I occasionally experience reflux. I'm seeing my oncologist next week for my usual 3 month visit. Thankfullly the pain has almost resolved. Pressure is no longer there. Feeling way less anxious about cancer recurrence.
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| 45 | 2021-02-03 | chest discomfort |
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 2...
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Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
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| 45 | 2021-02-03 | hypertension, heart rate increased, chest discomfort |
Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. ...
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Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
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| 45 | 2021-02-03 | hypertension |
Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; St...
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Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
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| 45 | 2021-02-04 | low blood oxigenation, anaemia, cardiac arrest, cardio-respiratory arrest, fibrin d dimer increased, haemoglobin decreased, very slow heart rate, platelet count decreased, fainting |
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate...
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In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
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| 45 | 2021-02-04 | heart rate increased, blood pressure increased |
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms...
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My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
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| 45 | 2021-02-04 | fainting |
Patient states that her physician advised against second dose. She states she had a severe headache ...
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Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.
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| 45 | 2021-02-04 | palpitations, chest pain |
headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; Thi...
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headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as 5730, pending clarification), via an unspecified route of administration on 18Dec2020 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 45 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included asthma and known allergies to epinephrine, latex, sulfa. Concomitant medications included amoxicillin (AMOXICILLIN), ibuprofen (MOTRIN). On 19Dec2020 at 01:00 PM the patient had headache and tiredness ever since get palpitations, chest pain, arm weakness when standing too long or when first get up. Heart doctor thinks it's due to vaccine or anxiety but never had this before shot. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment for the events included anti anxiety medication, metoprolol. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination the patient was tested for COVID-19 (nasal swab) on 18Jan2021 which resulted negative. Information about lot/batch number has been requested.
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| 45 | 2021-02-07 | heart rate decreased |
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl...
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Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
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| 45 | 2021-02-07 | cerebrovascular accident | Employee reports having a stroke 2 weeks after vaccination that required hospitalization. |
| 45 | 2021-02-07 | palpitations |
Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from...
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Pt c/o roof of mouth and tingling tongue. Pt c/o racing heart and sweaty palms. Pt was observed from 1:25pm-2pm when she stated that she was ok and wanted to go. Pt was initially offered 911 transport but declined. Pt then went to her car and felt worse. Re presented to the clinic and then 911 was initiated.
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| 45 | 2021-02-08 | lightheadedness |
Patient experienced a vagal response approximately 5 minutes after receiving the vaccine. Patient t...
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Patient experienced a vagal response approximately 5 minutes after receiving the vaccine. Patient transported to ED via EMS - seen and discharged.
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| 45 | 2021-02-08 | loss of consciousness, fainting |
Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-y...
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Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 45 | 2021-02-08 | blood pressure increased, fainting |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-09 | heart rate increased |
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report...
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metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
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| 45 | 2021-02-09 | vaginal haemorrhage, nosebleed | ~9 days of vaginal spotting (in between menses), and several mild nosebleeds. |
| 45 | 2021-02-10 | chest discomfort |
Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficul...
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Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficulty getting up from a sitting position. Missed work on week 3. Worsened each week until that point. Improves with rest but worse after on feet more. Extreme exhaustion. Some chest pressure started on week 2
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| 45 | 2021-02-14 | loss of consciousness |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-14 | heart rate increased |
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n...
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stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 45 | 2021-02-16 | ischemic chest pain, cardiac arrhythmia |
After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minut...
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After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minutes. Almost 7 hours later and the pain has increased to the surrounding area in an approximate 2" radius around the site of injection. I am also experiencing a lymphatic response, mostly felt in my neck, and also have some muscle soreness in my neck. I also experienced a few PVCs...I was diagnosed 4 years ago with heart arrhythmia that was mitigated through reduction of stress and caffeine. So, I don't consider it to be a "chronic" condition and it is not something I normally experience, but I have felt a few PVCs happen since being vaccinated today along with some very mild heart pain that is just beginning. For treatment of muscle soreness at injection site, I am just applying a bit of ice. For lymph nodes, I've been doing some lymphatic exercises and trying to not to sit too much. I also have a little bit of headache that is just developing. These symptoms are mildly uncomfortable over all. The arm tenderness does give me a general feeling of discomfort and limits my desire for movement, but does not seem to impede my ability to move. For headache, I would normally take a 400 mg of ibuprofen, but I'm not going to take any kind of NSAID at this time. I will monitor my heart but am not concerned. I cannot be certain the vaccine is the cause of any of these symptoms, except for the arm tenderness and probably the lymphatic response as well. Headache and PVCs can be caused by a lack of sleep and possible dehydration, and I've had a bit more caffeine than I normally might.
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| 45 | 2021-02-16 | fainting |
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co...
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Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-16 | chest pain |
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin...
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Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
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| 45 | 2021-02-16 | heart flutter, chest discomfort, palpitations |
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (flutt...
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injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
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| 45 | 2021-02-17 | lightheadedness |
Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood oc...
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Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
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| 45 | 2021-02-17 | lightheadedness |
Vasovagal response; This is a spontaneous report from a contactable consumer. A 45-year-old female ...
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Vasovagal response; This is a spontaneous report from a contactable consumer. A 45-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) into the left arm on 01Feb2021 08:15 AM at single dose for COVID-19 immunization. Age at vaccination 45 years. Concomitant drugs included multi-vitamin, D3, AERids eye vitamins. The patient had not history of allergies to medications, food, or other products. On 01Feb2021 at 08:30 AM the patient experienced a vasovagal response.Occupational Health/Wellness nurse checked blood pressure and had her lay down with legs up. After 10 minutes she went away and felt back to normal. No treatment was received. The outcome was recovered.
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| 45 | 2021-02-18 | lightheadedness | felt faint - ?vasovagal rxn |
| 45 | 2021-02-22 | chest discomfort |
The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny f...
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The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain." The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol
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| 45 | 2021-02-23 | blood glucose increased, heart rate increased, blood pressure increased |
3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood ...
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3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose . This lasted till 2/20 until around 5:30 pm
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| 45 | 2021-02-23 | chest pain, blood pressure increased |
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo...
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Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-02-23 | chest pain |
headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with stron...
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headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
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| 45 | 2021-02-24 | fainting, loss of consciousness |
pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal a...
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pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed. IV started. pt then taken to local hospital for further eval.
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| 45 | 2021-02-25 | fainting |
The patient presents with symptoms that started immediately after pt received her first covid vaccin...
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The patient presents with symptoms that started immediately after pt received her first covid vaccine around 1000 today at center. she developed lightheadedness, sob, nausea, h/a, and when er triage nurse was triaging her she syncopized for 3-4 seconds. no fall. pt was seated. and pt also reports that earlier she felt like the room was spinning. Tx in the ED w zofran and discharged.
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| 45 | 2021-02-26 | chest discomfort, lightheadedness |
Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainti...
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Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainting. Minor chest pressure
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| 45 | 2021-02-28 | chest discomfort | Chest pressure 10 min after injection Throat tightness couple mins later |
| 45 | 2021-02-28 | chest discomfort |
Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear he...
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Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.
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| 45 | 2021-02-28 | chest discomfort |
Same day of vaccine later on that night I started getting a headache. The next morning I felt body a...
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Same day of vaccine later on that night I started getting a headache. The next morning I felt body aches, tired, as the day went on I started feeling tightness of chest, had to take deep breath this was around 10 or 11am then my supervisor said to go to the ER, They did an x-ray & covid test it came out negative & in the x-ray came back normal.
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| 45 | 2021-02-28 | fainting, hypotension |
Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female wi...
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Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female with history of hypertension, anxiety. Patient received vaccination at 14: 05, approximately 5 minutes later at 14:10, Vasovagal response
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| 45 | 2021-02-28 | hypertension |
Very high Blood Pressure that was fluctuating but not lowering for several hours. Sent to ER after ...
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Very high Blood Pressure that was fluctuating but not lowering for several hours. Sent to ER after 1.5 hours at the clinic. No treatment given at ER, Bloodwork, urine, and ECG all normal with no indication of any type of organ damage resulting from uncontrolled High Blood Pressure. Sent home after 3 hours with blood pressure of 179/95 and pulse rate of 104 with recommendation to monitor blood pressure and follow up with primary care. By Feb 13 blood pressure became normal and has stayed in the normal range.
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| 45 | 2021-02-28 | fainting |
after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to g...
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after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to go on anti vert and anti nausea meds, now 1 month later, I am still dizzy in the morning, my muscles ache terrible , especially my lower leg muscles , joint pain, and I am so exhausted
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| 45 | 2021-03-01 | oxygen saturation decreased |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-01 | heart rate increased |
Patient in observation after her 1st Pfizer injection when she reported feeling her heart beating fa...
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Patient in observation after her 1st Pfizer injection when she reported feeling her heart beating fast and complaining
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| 45 | 2021-03-02 | pallor, loss of consciousness |
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes...
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Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
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| 45 | 2021-03-03 | heart rate increased |
fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receivi...
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fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receiving the second shot.
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| 45 | 2021-03-04 | fainting |
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a...
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Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 45 | 2021-03-04 | chest pain |
chest pain; Shortness of breath; This is a spontaneous report from a contactable other health profes...
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chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-03-05 | palpitations, chest discomfort, fast heart rate |
While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccinati...
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While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccination. Assessed by on-site EMS. Patient reported palpitations and chest-tightness. Vital signs taken by EMS. At 1815 BP 141/88 HR 104. At 1817, BP 160/101 HR 150. HR 168 per EMS. Based on tachycardia and symptoms, decision was made to transport to ER. Patient denied any significant health history or previous vaccine adverse events. Patient transported via ambulance.
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| 45 | 2021-03-06 | blood pressure increased |
Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started...
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Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started to feel lightheaded and just weird. I was taken to lay down. My blood pressure was taken and it was elevated. I don't recall the exact numbers. I then began to develop hives on my chest and neck and a few minutes later I began coughing. An ambulance was already on site. They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi. The coughing subsided for about 10 minutes then began again. I was given another 25 mg of Benadryl. At the hospital I was observed. At approximately 5:30 I began to cough again. It was decided that I needed steroids and was given steroids in my IV. Once I stopped coughing I was discharged and sent home with a prescription for steroids and an Epi-pen
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| 45 | 2021-03-06 | heart rate increased |
Patient received her vaccine at 1343. She was seated in the 15 minute waiting area. She went to the...
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Patient received her vaccine at 1343. She was seated in the 15 minute waiting area. She went to the RN observation desk to check out at 1405 when her observation time was up. Nurse educated patient about signs/symptoms to watch out for in the next 48 hours, including tachycardia. Patient then shared that her heart rate had been elevated since her injection. She states she thought it was just nerves/anxiety, but thought that she should mention it now. Nurse directed her to EMS for evaluation. This RN accompanied patient to EMS where she was placed on a monitor. Patient stated she was tracking her own pulse via smartwatch, reported it to be in the 130's just after injection. She stated she was able to bring it down to the 80's while sitting. Per EMS, her pulse was stable in the high 90's. Patient reports a history of childhood tachycardia, but states she was cleared by her cardiologist 5+ years ago. She takes daily synthroid, prescription zyrtec, pantoprazole, and celexa. She has PRN ativan for anxiety, takes it infrequently. She took all of her scheduled medication this morning. She has an allergy to erythromycin (GI cramping) and penicillin (hives in childhood). EMS performed 12 lead EKG at 1421 -- Normal Sinus Rhythm, vital signs 118/78, pulse 89, oxygen 99%. Second set of vitals at 1430 were 109/78, pulse 86, oxygen 99%. Patient reports feeling fine, would like to go home if cleared. EMS agreed. RN reminded patient to watch for symptoms over the next 48 hours, to call 911 if she has any additional cardiac symptoms, any oral swelling, difficulty breathing or swallowing, hoarseness, chest pain or tightness. She will follow up with her primary care physician for direction about the booster vaccine. She requested that the notes be sent to her primary care and cardiologist (RN unable to find cardiologist in her record, patient could not recall his name at this time).
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| 45 | 2021-03-07 | heart rate increased, fainting |
Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and receive...
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Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and received IV fluids and Zofran, monitored and discharged to home.
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| 45 | 2021-03-07 | fainting |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-09 | lightheadedness |
Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with b...
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Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with blood draws and vaccination during her college years. client stated tingly on left upper chest for just a few seconds. denies chest pain, shortness of breath or dizziness. Client vitals were take at 15:26 with spo2 97, pr 54, BP 147/62, vital #2 at 15:31 spo2 98, pr 67, BP 140/85, vitals #3 15:48 spo2 98, pr 71, bp 150/88. Client was advised to go to an urgent care/ emergency room for further monitoring. Client's son will be transporting.
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| 45 | 2021-03-11 | chest discomfort, heart rate increased |
pt reported feeling itchy, elevated heartrate, nauseous, drowsy, tightness in chest. Pt informed vac...
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pt reported feeling itchy, elevated heartrate, nauseous, drowsy, tightness in chest. Pt informed vaccinator before injection that these side effects are common when she gets vaccinated. She took a dye free benadryl at home before her appt. She was checked on 15 minutes after the injection and she reported the above reaction. She wanted to go home but was convinced to remain in the waiting area and given 25mg gelcap of dye free benadryl. After waiting for a little while she decided to go home with the person she came to her appt with. She did not want to wait any longer. She said this reaction was not abnormal and she just wanted to lie down. She was told we will call soon to check on her.
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| 45 | 2021-03-12 | heart rate decreased |
On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm,...
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On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm, I experienced difficulty in breathing and had a slow heart rate. In addition to muscle pain on my left arm where I got the shot, whenever I almost felt into sleep I was startled and woke up from short of breath. I wore a watch to check on my heart rate. On the low end it went into 53 ~ 54 especially when I felt short of breath. On the high end it was around 67 ~ 70 which is my normal heat beat when at rest.
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| 45 | 2021-03-13 | palpitations, heart rate irregular | Irregular heartbeat. Pumping harder, not faster. |
| 45 | 2021-03-15 | palpitations |
"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER co...
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"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER covid-19 vaccine, self limited BP 110/83 O2Sat 100% pulse 80, feeling better, refused ER ,HX anxiety disorder"
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| 45 | 2021-03-15 | palpitations |
After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. ...
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After 20-25 mins, heart started racing, swelling started on lips, eyelids, neck , inside the mouth. Felt burning sensation in esophagus. Experience tiredness, chill and minor diziness as well. Took Benadryl every 8 hrs and pepcid from over the counter. There is still minor swelling and continuing the benadryl after 24 hrs
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| 45 | 2021-03-15 | heart rate increased |
Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vac...
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Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vaccine was administered and subsided about 2 hours later. Primary care physician suggested that skipping breakfast may have been a contributing factor (I sometimes skip breakfast; I had not eaten for about 14.5 hours at the time the vaccine was administered).
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| 45 | 2021-03-15 | fast heart rate |
Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 11...
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Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 113/116), extreme chills with shaking ( 4 blankets on me), followed by extreme sweating for 1 hr. After that I was fine as had no other symptoms.
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| 45 | 2021-03-15 | fast heart rate, hypertension | VS 170/100, 112; Anxiety, tachcardia, hypertensive, no meds given, patients resolved. |
| 45 | 2021-03-17 | blood glucose increased, deep vein blood clot, pulmonary embolism, blood clot |
Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care so...
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Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care sought at Urgent Care on 01/18/21. Started on Eliquis 01/18/2021.
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| 45 | 2021-03-17 | increased heart rate, chest pain, palpitations |
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vac...
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Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.
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| 45 | 2021-03-17 | lightheadedness, fast heart rate |
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health c...
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body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-03-18 | blood pressure increased |
20 minutes after injection, I experienced a significant increase in blood pressure (177/103), dizzin...
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20 minutes after injection, I experienced a significant increase in blood pressure (177/103), dizziness and headache. As of 12 hours later, symptoms have not resolved.
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| 45 | 2021-03-18 | deep vein blood clot |
two weeks after vaccination, pt developed significant DVT throughout venous system of leg. Had bee...
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two weeks after vaccination, pt developed significant DVT throughout venous system of leg. Had been extremely sedentary from msk injury sustained 3 days prior to vaccine
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| 45 | 2021-03-19 | palpitations, heart rate increased |
1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband broug...
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1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband brought to pt. BP-142/90 with heart rate 132. Chest and face flush. Received 25 mg benadryl po. Pt stated she was feeling better. 1610-BP-124/82 with heart rate 117. 1615-Pt started c/o of heart racing again. Heart rate 130 and pt now c/o sob and headache. BP-140/84.
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| 45 | 2021-03-19 | chest pain | chest pain, fatigue, headaches, chills, arms soreness, insomnia |
| 45 | 2021-03-20 | fainting | 5 hours after receiving the shot I fainted |
| 45 | 2021-03-20 | chest discomfort |
Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injecti...
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Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).
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| 45 | 2021-03-21 | cardiac arrhythmia, chest discomfort, heart rate increased, palpitations, heart flutter |
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in...
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Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
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| 45 | 2021-03-21 | blood pressure increased |
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st...
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after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
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| 45 | 2021-03-22 | chest discomfort |
10 - 15 minutes following the vaccine (administration), the patient became nauseous, lightheaded, an...
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10 - 15 minutes following the vaccine (administration), the patient became nauseous, lightheaded, and developed mild chest tightness
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| 45 | 2021-03-22 | palpitations, chest discomfort |
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he...
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5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
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| 45 | 2021-03-22 | heart rate increased |
After patient had received her first dose of Pfizer, she went to the observation area. Shortly after...
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After patient had received her first dose of Pfizer, she went to the observation area. Shortly after arriving, she stated to feel dizzy. EMT's on site assessed her per the nurses request. Patient vomited soon after being put on a monitor, her heart rate was elevated at that time. When her vomiting ceased, she stated that she felt much better. She denied feeling sick prior to having her vaccine. EMT's offered her a ride to the ER to have her checked out. The patient accepted the ride to the ER after being offered a few times. She requested some water for the ride, at which time she was provided a bottle of water for the trip. The patient stated she would call her family to notify them, and have them pick up her children in the event she could not do so herself later in the day.
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| 45 | 2021-03-22 | blood pressure increased |
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ...
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Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
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| 45 | 2021-03-22 | chest discomfort, hypertension |
Extreme dizziness and nausea immediately following injection, lasted for over an hour. After 10 min...
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Extreme dizziness and nausea immediately following injection, lasted for over an hour. After 10 minutes following injection a strong wave of nausea started in pit of stomach and moved up through abdomen to chest, then felt moderate chest pressure and warmth, lasting about 3-5minutes. Blood pressure was 177/110 and pulse was 138 approximately 15minutes following injection and sustained this high for another 20minutes. After an hour of observation, went home and experienced significant exhaustion and drowsiness.
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| 45 | 2021-03-22 | blood pressure increased | Felt dizzy, BP increased, chills. Transported to ER by EMS. |
| 45 | 2021-03-22 | hypotension |
Patient complained of dizziness after receiving vaccination at 7:45. Patient did not eat breakfast. ...
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Patient complained of dizziness after receiving vaccination at 7:45. Patient did not eat breakfast. She was slightly hypotensive and was given a snack and water. Patient still feeling light-headed at 8:00, however stated this is common for her. At 8:23, she reported feeling better.
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| 45 | 2021-03-22 | fast heart rate, palpitations |
Pfizer-BioNTech COVID-19 Vaccine EUA around 2:30 am began having chills, and muscular aches both of...
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Pfizer-BioNTech COVID-19 Vaccine EUA around 2:30 am began having chills, and muscular aches both of which continued for approximately 18 hours. around 7:30 am began also having headaches which persisted for about 12 hours. Also had fatigue, possible due to not sleeping well due to sx. Around 10:00 am began having difficulty concentrating, headaches, muscle aches and chills intensified. Around 11am confirmed fever of 100 d F, took Tylenol which lessened chills. General malaise continued through evening, 8pm, took another Tylenol, by 9 pm began having series of intense and persistent (nonstop) heart related symptoms (chest pounding, tachycardia, shortness of breath,) which continued for several hours. (exact time unknown, I am guessing it lessened around 2am or so.) Following am, all symptoms gone. (might have continued to have some intermittent heart stuff as that has been ongoing every day, but non-stop intense cardiac feelings were not continuing by morning.
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| 45 | 2021-03-23 | chest discomfort, palpitations |
46 yo female presents for "palpitation" and chest tightness x 15 min. She reports that she has hx of...
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46 yo female presents for "palpitation" and chest tightness x 15 min. She reports that she has hx of ASD closure 5 years ago but has not taken any meds. At the moment she feels "nervous" and anxious. Consulted with Dr. , Dr, ok'd to go home.
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| 45 | 2021-03-23 | hypertension, haemoglobin decreased, fainting, loss of consciousness |
High BP 180/102 at doctors office resulting in prescription for Lisinopril with Hydrochlorothiazide,...
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High BP 180/102 at doctors office resulting in prescription for Lisinopril with Hydrochlorothiazide, Vasovagal syncope resulted in loss of consciousness, falling and hitting head on bathtub.
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| 45 | 2021-03-23 | heart rate increased |
I had severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 h...
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I had severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. I developed an eye infection for which I had to go to the doctor. I am currently doing eye drop treatments for this as well as topical lid scrubs. The anxiety / panic continues. I had extreme fatigue for several weeks. Other symptoms lasted 48 hours.
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| 45 | 2021-03-24 | blood glucose increased |
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine...
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Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
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| 45 | 2021-03-24 | hypertension, heart rate increased, chest discomfort |
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high bl...
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Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.
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| 45 | 2021-03-24 | blood pressure increased |
blood pressure was at 203/118; light headed; This is a spontaneous report from a contactable consume...
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blood pressure was at 203/118; light headed; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, expiration date not provided), via an unspecified route of administration, at the age of 45 years old, administered in Left arm on 12Mar2021 14:30 at single dose for covid-19 immunisation. Medical history reported as none and there were no known allergies. There were no concomitant medications. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not test for covid-19 post vaccination. The patient experienced blood pressure was at 203/118 and light headed on 12Mar2021 14:45. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Specifically, it was reported that within 15 minutes of having the vaccine at 14:45 12Mar2021, the patient started feeling light headed, head pressure. Paramedics came to check on her and found out her blood pressure was at 203/118. The patient ended up in the emergency room on Friday 12Mar2021, again on 13Mar2021 for another incident of high blood pressure and on 16Mar2021 and her blood pressure was still high. The patient has never suffered of high blood pressure until after the vaccine. The patient's doctor has prescribed blood pressure meds and will monitor for two weeks to see if it can bring blood pressure down. Treatment Hydrocochlorothiazide 12.5mg and Lozartan were taken as a result of events blood pressure increased and light headedness. The outcome of the events was not recovered.
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| 45 | 2021-03-24 | palpitations | pt c/o dizziness and palpitations v/s 99RA 75bpm, 19cpm BP 148/81 |
| 45 | 2021-03-25 | palpitations |
Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 app...
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Patient received her 1st dose of Covid-19 vaccine, Lot #ER2613, in her left deltoid on 3/25/2021 approximately 11:53am at the Vaccination Clinic at the Medical Center. While waiting in the parking lot, patient honked her horn and alerted medics she was not feeling well. Reaction occurred at approximately 12:40pm. Patient had tongue swelling, racing heart, and lightheadedness. Medics took vital signs and administered 0.3ml Epinephrine IM. Patient was transported to Medical Center.
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| 45 | 2021-03-26 | pulmonary embolism, chest pain |
I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain...
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I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain, shortness of breath, sweating and chills. I went to the ER, and they discovered two blood clots in my lungs. I've never had pulmonary embolisms before, so this is a very strange coincidence. I am in cancer treatment, so my risk of PEs is higher, but the timing is too close for me not to think that the second vaccine traumatized my immune system, causing the PEs.
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| 45 | 2021-03-26 | fast heart rate | fever, severe chills, tachycardia, diaphoresis, nausea, migraine |
| 45 | 2021-03-28 | blood pressure increased |
20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat starte...
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20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat started to swell. This is a typical mast cell reaction for me. I took 20 mg of Fomatadine a few minutes later. I had already had 50mg Bendryl on board. About 20 minutes after the Fomatadine the swelling in the throat started to improve slightly. I left the facility where I had the shot after about an hour and my condition did not worsen. I fulle recovered in about 48 hours.
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| 45 | 2021-03-30 | deep vein blood clot |
Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; ...
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Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-03-30 | chest pain |
Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Heada...
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Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021. Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
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| 45 | 2021-03-30 | chest pain |
Fever; Body ache; Severe chest pain behind my sternum around; it was very sharp; Back pain; This is ...
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Fever; Body ache; Severe chest pain behind my sternum around; it was very sharp; Back pain; This is a spontaneous report from a contactable Nurse. This 45-year-old female nurse (Patient) reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN9581), is Covid-19 Vaccine a Pfizer product; Yes, covid-19 vaccine manufacturer; unspecified, NDC number, UPC number, expiry date; unknown via an unspecified route of administration from 03Feb2021 to 03Feb2021 at single dose (dose number; 2) for covid-19 immunisation. Patient was 45 years old at the time of vaccination with weight 56.7 kg and height; 152 cm. Patient's medical history included tremor (dates unspecified). Past drug included oxycodone hydrochloride, paracetamol (PERCOCET, Batch/lot number; unknown), Is Percocet a Pfizer product; unspecified, Percocet manufacturer; unspecified, NDC number of Percocet; unknown, UPC number of Percocet; unknown, reason for no lot number of Percocet: not probed over call, call back unsuccessful, expiry date of Percocet; unknown; I don't use Percocet, I am allergic to Percocet (dates unspecified). Patient's concomitant medications included Primidone for tremor (therapy dates unspecified). Nurse (consumer) stated, "I was just calling to report a side effect, I received my second dose of Covid-19 Vaccine on Wednesday (03Feb2021) and on Thursday (04Feb2021) has started normal side effects with fever and aches "something like that" (not clarified) and I had some severe chest pain behind my sternum around the "muscle pain" (not clarified) and it was very sharp it only responded to antacids (treatment) and I had to continually to take them and this lasted probably 18 hours." When paraphrased the concern, Nurse stated, "Yes, I don't have fever, I had fever and body ache." When probed for reporter type (HCP), Nurse stated, "I am a Midwife and Nurse." When probed for the start date of the event (problems), Nurse stated, "It was yesterday about probably 20 hours after my back pain (04Feb2021)." When probed if any doctors prescribed the vaccine, Nurse, stated, "I have no idea, I went to a Vaccination Centre." When probed for specialty if vaccine prescribed by any doctor, Nurse, stated "Again I don't know that's all I got on vaccination site." When probed for the follow consent with the facility center, Nurse stated, "Yes." When probed date of vaccine (second dose) administration, Nurse stated, "It's on 03Feb2021." When probed for vaccine expiration date, Nurse stated, "I don't think, that's not on here." When probed for vaccine NDC#, Nurse stated, "No that's not on here either." When probed for vaccine (UPC#), Nurse stated, "Not on here either". When probed for causality, Nurse stated, "Yes due to the vaccine." When probed for vaccine dose, Nurse stated, "I don't know (incomplete sentence)." Nurse added, "I don't use Percocet, I am allergic to Percocet. Forget the Percocet that's an allergy." When probed if any concomitant medication, Nurse stated, "I am using other medication "Condom" (not clarified) just birth control contraception." When probed still having the problems (event), Nurse stated, "No, it lasted about 18 hours (incomplete sentence)." When probed for if the event has been worsened, improved and persisting Nurse stated "I feel like it's resolved." When probe to confirm the treatment for the problems, Nurse stated, "Yes, I took Antacids." Investigation Assessment: No. The outcome of events was recovered on an unknown date.
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| 45 | 2021-04-01 | blood clot |
Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient ...
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Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.
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| 45 | 2021-04-01 | fast heart rate |
Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is ...
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Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events tachycardia and rash to the vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.
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| 45 | 2021-04-12 | haemoglobin decreased | No adverse events for 1st dose, 2nd dose was temporally correlated with autoimmune hemolytic anemia |
| 45 | 2021-04-13 | pulmonary embolism, blood clot, anaemia, excessive bleeding |
Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. D...
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Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. Due to fibroids, this caused excessive bleeding leading to anemic condition and the need for several blood and iron transfusions. Solution was to perform hysterectomy to eliminate fibroids and bleeding to be able to continue use of blood thinners for blood clot condition.
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| 45 | 2021-04-13 | cerebrovascular accident |
Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn...
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Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.
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| 45 | 2021-04-18 | fibrin d dimer increased | Blood clot in right subclavian vein on March 1. |
| 45 | 2021-04-19 | ischaemic stroke | 2 Ischemic strokes on right side of brain due to blood clots |
| 45 | 2021-04-20 | heart attack |
immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consu...
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immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown. Follow-up attempts are needed. Further information on the lot/batch number has been requested.
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| 45 | 2021-04-24 | loss of consciousness |
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d...
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is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-26 | heart rate increased, ischemic chest pain, blood pressure decreased |
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness...
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Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
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| 45 | 2021-04-30 | fainting, heart rate increased |
it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Uri...
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it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Urinated on self/Wet her pants; Headaches; Feeling light headed; Felt her heart beat faster; Sore arm; This is a spontaneous report from a contactable nurse (patient mother). A 45-year-old female patient received bnt162b2 (BNT162B2, lot number EW0150 and expiration date was not provided), via an unspecified route of administration first dose on 05Apr2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included ongoing Hypertension (Patient diagnosed in her late 30's), ongoing Hypothyroid (Patient diagnosed when she was around 20 years old), ongoing Allergies, ongoing Gastrooesophageal reflux disease (The patient was exposed to a chemical in her 20's that caused this condition), ongoing Birth control, ongoing Allergic to eggs (States patient has never received the flu vaccine due to her egg allergy), and ongoing Allergic to shellfish. The patient's concomitant medications included ongoing levothyroxine at 150 ug, 1x/day for Hypothyroid, ongoing Hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, ongoing omeprazole at 20 mg, 1x/day for gastrooesophageal reflux disease, ongoing losartan at 100 mg, 1x/day for hypertension, ongoing norethisterone (SHAROBEL) for Birth control. On 06Apr2021 13:00, the reporter stated that her daughter fainted at work, lost her urine, and was unconscious and was taken to the Emergency Room. Primary Care Physician told her daughter she should have no problem getting the second vaccine. States that she was not certain if her daughter should get the second shot. It was scheduled for next week. Also, reported that after lunch reporter stated that her daughter fainted in her office at work. She had urinated on herself and was unconscious. Caller was concerned it could have been a seizure. Her daughter was taken to the Emergency Room and they diagnosed her as having a Syncopal Episode. On 06Apr2021, the patient had headaches that continue since these events. The reporter stated that her daughter's doctor told her daughter that the blood work and electrocardiogram done at the Emergency Room were normal. The Emergency Room and her daughter's doctor acted like her symptoms were not serious. The reporter looked at the Vaccine Adverse Event Reporting System website and it said that a syncopal episode is a reportable event. Says that her daughter's doctors did not report this event. Says doctors need to have training on the importance of reporting events. The reporter called the Food and Drug Administration last week but she hasn't heard anything from them. States they told her it could take 5-7 business days. Says she called Pfizer today to see if there was any further information or guidance she could get as she is concerned about her daughter. She says her daughter has her own office so she was in there alone when she collapsed. Someone found her on the floor. The reporter was asking for guidance on administration of the second vaccine dose following a syncopal episode after the first. The patient received her first vaccine dose on 05Apr2021 15:00 and she was fine, she had a sore arm, but went to work the next day (06Apr2021) and after lunch she reported feeling light headed and felt her heart beat faster and went to get up and a colleague later found her on the floor and she had wet her pants. They took her to the ER around 1 pm the day after her vaccination and diagnosed her with a syncopal episode stating that they didn't think it was from the shot. The events syncope, urinary incontinence, seizure, and headache were considered as serious (medically significant) by the reporter. The events syncope, and urinary incontinence caused emergency room visit and physician office visit. The outcome of the events syncope, urinary incontinence was recovered on 06Apr2021. The outcome of the event Headache was not recovered. The outcome of the remaining events was unknown.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 45 | 2021-05-04 | heart rate increased |
Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining consc...
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Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining conscious and numbness in my face.
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| 45 | 2021-05-05 | hypertension, chest pain, chest discomfort, blood clot |
Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (m...
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Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (menstrual bleeding) and lasted for 2.5 days Chest pain continued and has not stopped for last 10 days, intermittent throughout the day - tigheting of left side and right side of chest, radiates to theback Sunday following Monday vaccination (6 days later) got a blood clot on palm of hand, lasted for 4 days that started bleeding out and blood spread to front of hand like a birthmark as it bleed out
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| 45 | 2021-05-07 | fainting |
Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneo...
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Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 08:45 as single dose for COVID-19 immunization in an hospital. Medical history included known allergy from an unknown date. There were no concomitant medications. No other vaccines taken in four weeks. No COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 10Apr2021 13:00, the patient experienced severe allergic reaction - hives, itching, burning, shortage of breath, fainting. She was unable to stand or sit, and had to call ambulance and go to emergency. The events resulted in emergency and physician's office visit and required hospitalization. The patient was given a steroid and unspecified allergy medications as treatment. The outcome of the events was reported as recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-05-09 | blood glucose increased |
After receiving my second Covid vaccine Phizer, my blood sugar started rising into uncontrollable le...
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After receiving my second Covid vaccine Phizer, my blood sugar started rising into uncontrollable levels. I ultimately went to the emergency room and was admitted to the ICU with diabetic keto acidosis believed to be caused by the vaccine.
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| 45 | 2021-05-09 | troponin increased, chest pain, inflammation of the heart muscle |
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau...
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Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
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| 45 | 2021-05-12 | inflammation of the pericardium, chest pain |
Pericarditis; Woke up with chest pain; Difficulty breathing; This is a spontaneous report from a con...
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Pericarditis; Woke up with chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on an unspecified date 02:00 PM in Apr2021 (Lot Number: EWO158) as single dose for COVID-19 immunization. Medical history included Interstitial cystitis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No and other medications the patient received within 2 weeks of vaccination. The patient experienced pericarditis (hospitalization) on 13Apr2021 00:30, woke up with chest pain (hospitalization) on 13Apr2021 00:30, difficulty breathing (hospitalization) on 13Apr2021 00:30. Patient was hospitalized from 13Apr2021 to 14Apr2021. Clinical course: Woke up with chest pain and difficulty breathing one week after first dose. Went to the hospital and was diagnosed with pericarditis. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse events which included anti-inflammatories and colchicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab Negative on 13Apr2021. Outcome of the events was recovering.
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| 46 | 2020-12-31 | palpitations, blood pressure increased |
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b...
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Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck Â
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| 46 | 2021-01-01 | lightheadedness |
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv...
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Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
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| 46 | 2021-01-01 | lightheadedness |
Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/1...
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Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.
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| 46 | 2021-01-04 | chest discomfort, blood pressure increased |
I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I start...
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I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.
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| 46 | 2021-01-04 | fast heart rate, heart rate increased |
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);...
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Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-04 | fast heart rate |
Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (...
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Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (1/1/21)developed fevers and right sided neck pain, tachycardia, myalgia
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| 46 | 2021-01-04 | chest discomfort |
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa...
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flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
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| 46 | 2021-01-05 | blood pressure increased, heart rate increased |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-05 | palpitations, cardiac arrhythmia |
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms...
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Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
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| 46 | 2021-01-05 | heart rate increased |
rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician rep...
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rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 46 | 2021-01-06 | fast heart rate, increased heart rate |
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris...
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01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
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| 46 | 2021-01-06 | palpitations, chest pain, fainting, blood pressure increased |
Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; Thi...
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Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
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| 46 | 2021-01-06 | chest pain |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | chest pain | Myalgia chest pain, bronchial spasm Narrative: |
| 46 | 2021-01-06 | blood pressure increased |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | chest discomfort, heart rate increased |
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had...
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Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
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| 46 | 2021-01-06 | heart rate increased |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | pallor |
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ...
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Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
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| 46 | 2021-01-06 | palpitations |
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he...
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jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-07 | chest discomfort | Chest tightness, headache, runny nose, mild cough. |
| 46 | 2021-01-07 | chest discomfort |
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin...
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Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
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| 46 | 2021-01-09 | heart rate increased, chest discomfort, blood pressure decreased |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-09 | palpitations | Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day |
| 46 | 2021-01-09 | heart rate increased |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-10 | hypertension, chest discomfort, heart rate increased, palpitations, troponin increased |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | blood glucose increased, chest pain |
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v...
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Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
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| 46 | 2021-01-10 | palpitations |
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID...
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The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
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| 46 | 2021-01-11 | chest pain |
Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest u...
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Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
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| 46 | 2021-01-12 | chest pain |
1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache,...
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1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.
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| 46 | 2021-01-12 | heart rate increased, loss of consciousness |
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa...
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Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
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| 46 | 2021-01-12 | loss of consciousness, heart rate increased |
Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:0...
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Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:00am on 1/13/2021, aches began, so I went downstairs to take acetaminophen. Increased heart rate and sweating while in the kitchen (had to sit down on the floor), eventually took Tylenol, and as I was heading back upstairs with cup of water, I passed out (less than 30 seconds) dropping the cup of water. Heaved/vomited small amount of liquid two or three times. Made it back to bed and began to feel better around 4:00am 1/13/2021.
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| 46 | 2021-01-12 | heart flutter | Heart fluttering |
| 46 | 2021-01-12 | palpitations, chest discomfort |
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactab...
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Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
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| 46 | 2021-01-12 | palpitations |
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho...
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Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
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| 46 | 2021-01-12 | chest discomfort | TIGHTNESS OF CHESS, FEELS LIKE I AM GOING TO GET AN ASTHMA ATTACK. SOME COUGHING DIZZINESS |
| 46 | 2021-01-12 | blood pressure increased, heart rate increased |
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha...
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The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
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| 46 | 2021-01-12 | fainting | headache nausea syncope |
| 46 | 2021-01-14 | chest discomfort |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-15 | palpitations |
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f...
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Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
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| 46 | 2021-01-16 | heart rate increased |
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h...
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24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
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| 46 | 2021-01-16 | chest pain |
Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain ove...
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Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain over the past night, but the sudden pain developed about 3 minutes before I came into her office. Pain was a 10/10 in severity and made it difficult to breathe and talk. She was able to tolerate snow blowing this morning without notable difficulty. Pain is not clearly exertional in nature.
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| 46 | 2021-01-17 | blood pressure increased |
I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ...
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I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more. I had sl elevated BP 148/86 and pulse ox at 97% and HR 95. Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.
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| 46 | 2021-01-18 | palpitations, chest discomfort |
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen...
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1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
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| 46 | 2021-01-18 | fainting | Fainted, chills sweating bodyaches and extremely bad headache |
| 46 | 2021-01-18 | hypertension, fast heart rate | Pain and numbness on L forearm near the injection site Mild hypertension and tachycardia |
| 46 | 2021-01-19 | chest discomfort |
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min...
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Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
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| 46 | 2021-01-20 | chest discomfort |
Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and...
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Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and needed prolonged monitoring post vaccination. Improved with rest.
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| 46 | 2021-01-20 | chest pain |
Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spo...
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Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spontaneous report from a contactable consumer (reporting for a patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 12:00 at a single dose for COVID-19 immunization. There was no other medical history, had no known allergies. Concomitant medications were not reported. The patient did not have COVID and did not receive other vaccine in four weeks prior to vaccination; did not have other medication within two weeks and was not pregnant at the time of vaccination. On 08Jan2021, the patient experienced occasional chills and mild chest pain with deep breath. No treatment was given for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 46 | 2021-01-20 | chest discomfort |
Patient developed one singular area of urticaria approximately one hour after the vaccination and th...
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Patient developed one singular area of urticaria approximately one hour after the vaccination and then developed an anaphylactoid reaction 3 days later including widespread urticaria and chest tightness. She took OTC antihistamines and recovered 6 days after the vaccine.
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| 46 | 2021-01-20 | nosebleed | nose hemorrhage for four days |
| 46 | 2021-01-21 | pallor |
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe...
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Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
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| 46 | 2021-01-21 | heart rate increased |
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ...
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allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-22 | palpitations, heart rate increased |
On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath...
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On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath, dizziness and increased heart rate with what felt like palpitations, as well as a massive headache. The symptoms resolved subsided after 10 minutes, but returned again shortly afterwards. After taking some Advil 200mg x 1, my symptoms improved but I still remained fatigued and had difficulty breathing at 100% the rest of the day. After the 2nd episode 911 was contacted and FD arrived at my home. All vital signs, pulse & O2 were WNL, except BP @ 153/99. I've had one previous experience with this and it was while taking Izoniazid as a TB prophylactic after a 6 month treatment. As of today, my symptoms have resolved and am back to my usual state.
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| 46 | 2021-01-22 | palpitations |
patient went back to the procedure center after receiving vaccine after 15 min observation and compl...
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patient went back to the procedure center after receiving vaccine after 15 min observation and complained of N, abdominal pain and out of body experience with inability to talk or describe what happened. Palpitations. No CP, SOB, wheezing or visual changes. HR 140's w occ PVCs, SBP 160-170's SpO2 100% with pt appearing flushed and drowsy. O2 NC, NS 1 liter IV, zofran 4mg IVP x1 given. Admitted to procedure center at 1500 and discharged at 2359.
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| 46 | 2021-01-24 | chest pain, very slow heart rate, fast heart rate |
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous...
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Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
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| 46 | 2021-01-24 | palpitations |
Individual started to feel her heart begin to race. she said she felt a little light-headed and her...
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Individual started to feel her heart begin to race. she said she felt a little light-headed and her vision was "off". She had a headache coming to the clinic which she had taken excedrine for prior to arriving. We took her blood pressure about 10 minutes after vaccination and it was 150/88 HR 130. We moved her into a private room to monitor and attempt to relax her. continued BP monitoring every 5-10 minutes- 148/92 147, 160/90 155. She stated that her left lip felt tingly so at that time we decided to call 911.
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| 46 | 2021-01-24 | chest discomfort |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | chest pain |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-24 | chest discomfort |
wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all t...
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wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all that night; Breast discomfort/describes the breast discomfort as a contracting feeling of encapsulation; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) injection intramuscularly in right arm on 21Dec2020 around 11:00 am at a single dose of COVID-19 immunization. Vaccination facility type was at medical center. Relevant medical history included acne, migraine, and chronic neck and upper back pain; all were ongoing, and breast implant, tennis elbow in left arm and she had the flu shot in Oct but she never got any reaction. She thought a side effect of spironolactone. Concomitant medications included rizatriptan benzoate (MAXALT, strength: 5mg, tablet) at 5mg tablet as needed for migraine, naproxen sodium (ALEVE, strength: 500mg, tablet) at 500 mg tablet, one tablet as needed for pain, and spironolactone (strength: 5mg tablet) (if her skin was breaking out she will take two tablets that night and if her face was not bad she will take one tablet) from Aug2020 for acne, breaking out; all were ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On 26Dec2020 she started feeling breast discomfort. She described the breast discomfort as a contracting feeling of encapsulation, reported it kept her up at night, she would have a heard time falling asleep or get no sleep at all that night. Her breast comfort started to lessen. The patient was breast discomfort or tenderness but she did not experience any breast discomfort till after she got the covid vaccine. She stated the breast discomfort was like a feeling that something was crawling inside, states it is like creepy crawlers. She also experienced a wet and cold sensation on her chest on 29Dec2020 and was still occurring once in a while, intermittently. At first it was just on the left breast, and the next night she felt the sensation across her chest, it felt like she spilled water and felt wet but it was not wt. She felt it while she was bed. She had breast implants. Last week she contacted her primary care doctor and she was sent to get a mammogram and ultrasound. She went to have the mammogram and ultrasound on Friday 08Jan2021 and everything was fine. She was thinking what she was experiencing was from the vaccine. The patient declined any treatment. No emergency room and no physician office required for the events. The outcome of event breast discomfort was resolving, of wet and cold sensation on chest was unknown.
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| 46 | 2021-01-25 | blood pressure increased | Felt warm and flushed with elevated Blood Pressure |
| 46 | 2021-01-25 | chest discomfort |
Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort J...
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Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort Joint discomfort
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| 46 | 2021-01-25 | cardiac arrhythmia, chest discomfort |
PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of ...
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PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of chest discomfort and breathlessness, and I went to the doctor. Their frequency/severity trended toward improving, but after the 2nd vaccine I was back to their original intensity/frequency. I do not have a history of similar. They are affecting my daily life. I've been referred to a Cardiologist.
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| 46 | 2021-01-25 | chest pain, heart rate irregular, palpitations, fainting |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-26 | chest pain, chest discomfort |
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i...
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Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
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| 46 | 2021-01-26 | heart rate increased |
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine...
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tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-28 | chest pain |
The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and ...
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The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and went away throughout the day. I woke up on 1/29/2021 and about 11:00 I started having the same pain again. I am more tired today. I have problems with acid reflux in the past usually after eating too much or during my menstrual cycle. I have been seen in hospital recently prior to covid vaccine and my heart is very great. I don't smoke or drink alcohol, no illicit drugs. I took Prevacid, it didn't help. The pain comes and goes with no aggravating or relieving factor.
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| 46 | 2021-01-28 | chest pain, pulse abnormal |
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ...
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pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
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| 46 | 2021-01-29 | palpitations |
A few hours after receiving vaccine, my heart started palpitating and would not stop. I have never e...
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A few hours after receiving vaccine, my heart started palpitating and would not stop. I have never experienced anything like this. I have NO previous medical problems and take no medications.
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| 46 | 2021-01-30 | deep vein blood clot |
Deep vein thrombosis right gastrocnemius vein and superficial venous thrombosis in right small saphe...
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Deep vein thrombosis right gastrocnemius vein and superficial venous thrombosis in right small saphenous vein diagnosed January 15, 2021. Symptoms began with acute onset right lower extremity calf pain and swelling on January 14, 2021. Treatment with Xarelto began January 15, 2021.
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| 46 | 2021-01-30 | chest discomfort |
Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry co...
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Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry cough. Headache started 1/25/21. Others started 1/26/21 and progressively got worse. Went to urgent care on 1/26. Missed work on 1/26 & 1/27.
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| 46 | 2021-01-30 | ischemic chest pain |
STABBING HEART PAIN FELT LIKE MY HEART STOPPED AND I GASPED FPR AIR AND HAD TO COUGH THIS HAPPEND W...
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STABBING HEART PAIN FELT LIKE MY HEART STOPPED AND I GASPED FPR AIR AND HAD TO COUGH THIS HAPPEND WITHIN SECONDS 3-5 TIMES A NIGHT FOR 2 WEEKS
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| 46 | 2021-01-31 | fast heart rate, chest pain, hypertension |
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old fe...
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This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital. Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm). Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events. The patient is recovering from the events. Information on the batch/lot number has been requested.
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| 46 | 2021-02-01 | chest discomfort, hypertension |
Chest tightness, shortness of breath, throat tickle then tightening, coughing, rash.... monitor ...
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Chest tightness, shortness of breath, throat tickle then tightening, coughing, rash.... monitor ( bp high, o2ok ekg looked like a fib then was ok) then epi, used inhaler, benadryl, epi and then taken to hospital where I received steroid injection and prilosec with continue monitoring. Next 5 days medrol pack, benadryl and prilosec
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| 46 | 2021-02-02 | fainting, loss of consciousness |
Patient mentioned that she had her second COVID vaccination earlier today at 0630 and hasn't been fe...
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Patient mentioned that she had her second COVID vaccination earlier today at 0630 and hasn't been feeling well since. She had breakfast around 0700 this morning. Patient was cleaning off a bed when she stated that she was nauseous and dizzy. She had a syncopal episode from standing, hitting her head on the floor. LOC for a few seconds and then awake. BP-138/90, FS-93.
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| 46 | 2021-02-03 | palpitations | -Palpitations -Rash -Tingling of Hands and Feet |
| 46 | 2021-02-03 | vaginal haemorrhage |
4 days post 2nd vaccine I started vaginal bleeding. Lasted 2 weeks. Bleeding stopped for a few day...
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4 days post 2nd vaccine I started vaginal bleeding. Lasted 2 weeks. Bleeding stopped for a few days then I started my regular period on my regular schedule
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| 46 | 2021-02-03 | palpitations |
Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46...
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Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration (left arm), on 18Jan2021 10:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. There were no concomitant medications. The patient experienced heart palpitations which began on 18Jan2021 the evening of taking the vaccine and have continued until now. Further reported that this adverse event started on 18Jan2021 10:00 AM. No treatment was received for the event reported. The patient was recovering from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
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| 46 | 2021-02-03 | chest discomfort |
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr...
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Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-03 | hypertension, fast heart rate |
pain and numbness on left forearm near the injection site; pain and numbness on left forearm near th...
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pain and numbness on left forearm near the injection site; pain and numbness on left forearm near the injection site; mild hypertension; tachycardia; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3249 and expiry date unknown) intramuscular at the left arm on 10Jan2021 at single dose for Covid-19 immunization in a hospital. Medical history was none. It was unknown if the patient was pregnant. The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. In Jan2021, the patient experienced pain and numbness on left forearm near the injection site, mild hypertension and tachycardia. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events pain and numbness on left forearm near the injection site was recovered in Jan2021, while mild hypertension and tachycardia was unknown.
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| 46 | 2021-02-04 | heart rate increased, blood pressure increased |
Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my sec...
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Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my second dose on 1/7/2020, I was still having COVID symptoms. Symptoms worsened after the second dose. My heart rate has been out of control. I have been on steroids daily, because I was so short of breath. I have not been at work since being diagnosed with COVID. I went ahead and got the second dose, because my job told me that I had to get the second dose. I still have fatigue, elevated heart rate, blood pressure is till elevated. I have been started on blood pressure medication. I have also been diagnosed with severe sleep apnea. I had a sleep study performed. I am on two new inhalers. One is a steroid inhaler for lungs and one is a rescue inhaler for when I am short of breath. It has not pleasant. Headaches are horrible and daily. I went to ER, because headache was so severe. No medication I take for headaches work. I have not been able to work since I was diagnosed with COVID.
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| 46 | 2021-02-04 | pallor, pulse abnormal, chest discomfort |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-07 | hypotension | Feeling warm, dizzy, light-headed, hypotensive |
| 46 | 2021-02-07 | heart rate increased, blood pressure increased |
Within three months, left arm which is the injection site, was struggling to lift up much at all, le...
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Within three months, left arm which is the injection site, was struggling to lift up much at all, left hand went tingly, once Nurse came saw that I had an increased pulse. When medics came through as increased pulse and increased blood pressure. Was cleared after about 15 minutes. The next day was decently sleepy with a decent headache. Then was fine.
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| 46 | 2021-02-08 | blood pressure increased |
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg s...
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0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl, 1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
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| 46 | 2021-02-08 | chest discomfort, fast heart rate, palpitations, blood pressure increased |
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th...
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7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
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| 46 | 2021-02-10 | blood pressure decreased |
- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymp...
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- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymph node on Ipsilalent side of shot - Concentration off BLOOD SUGARS SLIGHT Elevation (129-132 fasting) Decrease in Blood Pressure to 104/76 (usually 120s to 130s/80s
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| 46 | 2021-02-10 | loss of consciousness |
After 10 min receiving the second dose I passed out during observation at the vaccination site, was ...
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After 10 min receiving the second dose I passed out during observation at the vaccination site, was rushed to the ER. They monitored me, gave me fluids and performed an EKG.
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| 46 | 2021-02-10 | lightheadedness, fainting |
Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. ...
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Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. Vasovagal symptoms: dizziness; vertigo; lightheadedness; near syncope and weakness. Sent to ED via ambulance from work. ED gave IV fluids and mescaline. Studies performed: EKG; CBC; and BMP. From ED MD note DC instructions: You came to our ER with concerns of dizziness after getting your covid vaccine. We evaluated you with labs, and provided you with meclizine and fluis. The results of our evaluation were reassuring, and we believe that the causes of your symptoms are not immediately life threatening and safe to follow up with your clinic doctors. We've prescribed you meclizine, take it as needed for dizziness. Administration error: no Clinic called No; Transferred to Emergency Department from workplace several hours after vaccine was administered.
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| 46 | 2021-02-10 | oxygen saturation decreased |
Two days following the first dose given 12/30/20 I had a nocturnal aspiration event that precipitate...
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Two days following the first dose given 12/30/20 I had a nocturnal aspiration event that precipitated a drop in oxygen saturation to 79/80, requiring the need for a breathing treatment and ongoing increased use of inhalants/nebulizer for 10 days. Also GI symptoms to include loose, frequent stools for approximately 10 days. I also experienced mild body aches. Two days following the first dose given 01/20/21 another instance of nocturnal aspiration occurred, not as severe as I was still sleeping with my head elevated since the previous occurrence. However this prolonged the use of inhalants for 2 weeks following. ALSO and what I would consider the most concerning is the flare up of occipital neuralgia. This was pre existing, however had not had a flare up since 2018. And even after trigger point injections (nerve blocks ) were administered on 02/05, this is continuing to persist.An appointment with the neurologist on 02/05, trigger point injections (nerve blocks ) were administered by the neurologist and he recommended returning to occupational therapy as needed for craniosacral treatment.
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| 46 | 2021-02-10 | blood glucose increased, fainting, hypotension |
Within 15-minutes of vaccination, the patient had a witnessed syncopal episode. The patient was not ...
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Within 15-minutes of vaccination, the patient had a witnessed syncopal episode. The patient was not in respiratory distress and sustained no injuries. Patient told EMS that she has a history of syncopal episodes and hypotension, also has been very stressed and did not eat breakfast. EMS managed patient's condition on-site. Patient was hypotensive (104/71) with a pulse of 60bpm. Accucheck FSBG noted at 190mg/dL. Patient passed orthostatic BP test. EMS recommended transport to hospital for evaluation, but the patient refused and left with husband.
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| 46 | 2021-02-11 | heart flutter, hypertension |
First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day ...
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First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day my boss was home with Covid. I did a Saliva test (covid test), while waiting for my test above my collar bone was swollen. I was generally not feeling well. I got my results on the 25th and it was negative. On the 30th I got heart fluttering, feelin racy. It went away. On the 1st, I felt so wiped out and heart was going nuts, and I went to get a EKG that was normal but my BP was high140/high 80. On the 4th I went back to work again and still felt horrible, dizzy and they sent me to the ER and had High BP and two normal EKG', and the hooked me up to a heart monitor for a week. With both shots I had insomnia of the walls. Second Dose: it was much better than 1st dose. The Monday after the 2nd dose I got a really bad headache. I drank some Pedialyte and took a 12 hour nap and felt great after.
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| 46 | 2021-02-14 | blood pressure increased, fast heart rate, chest pain | Patient flushed, tachycardia, elevated BP, headache, nausea, vomiting, chest pain |
| 46 | 2021-02-16 | chest pain, palpitations |
I had severe palpitations that began 3 to 4 days after the vaccine. It felt like I was being stabb...
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I had severe palpitations that began 3 to 4 days after the vaccine. It felt like I was being stabbed in my chest with radiation into my neck. This lasted 2 to 3 weeks. I did go to the ED on 01/05/2021. I saw a cardiologist on 01/13/2021. I did get Dose 2 of the vaccine with the same symptoms but they were milder. I was put on an Event Monitor the week after Dose 2
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| 46 | 2021-02-17 | blood pressure increased |
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl...
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tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
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| 46 | 2021-02-18 | heart rate abnormal |
CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingl...
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CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingling in her mouth and tongue/lip swelling and dry mouth. Denies difficulty swallowing) Assessment/Plan: DIAGNOSIS at time of disposition: 1. Allergic reaction, initial encounter Symptoms: Patient had second dose of COVID 19 vaccine today at 1230 p.m. She states at around 530 - 6 p.m. she started coughing and felt like that was a hair caught in the back of her throat, states throat is tingling and looked in the mirror and states her tongue is swollen. Feels that her heart rate is abnormal, but states it could relate to anxiety. COVID vaccine clearance needed if future booster needed. Informed patient to follow up with PCP if needed after ED visit. HISTORY OF PRESENT ILLNESS: The patient got her 2nd dose of COVID vaccine today at noon. At 5 she started feeling a bit of a tickle and scratchiness of her throat and her mouth felt very dry. She was concerned about allergic reaction. No shortness of breath chest pain rash itching hives or any other concerns. She has not taken any Benadryl. The patient is in no distress. Symptoms been going on for 3 hours. This could be a very mild allergic reaction. Therefore I am giving her 50 mg of oral Benadryl. Given the symptoms been going on for 3 hours and I do not see any angioedema I am comfortable letting her go home at this point in time. I do not think steroids would be beneficial. She will return here if worsening and I instructed her to use Benadryl 50 mg every 4-6 hours if needed. BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 171/98, HTN (>/=140/90), recommend follow up with PCP within 1 month.
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| 46 | 2021-02-18 | blood pressure increased |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-19 | cerebrovascular accident |
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ...
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24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
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| 46 | 2021-02-21 | pulmonary embolism |
Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, ...
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Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged
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| 46 | 2021-02-22 | blood pressure increased |
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight...
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C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
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| 46 | 2021-02-22 | chest discomfort | Heaviness in chest. Swelling on face , eyes and lips |
| 46 | 2021-02-23 | chest pain, blood pressure increased |
patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness ...
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patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath. She was speaking softly, SaO2 was 98. Provided gatoraid and offered weather. Husband stated she had previous similar reaction post-anesthesia. at 1515. Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528- Unable to stand requesting an ambulance. a1530- EMS called at 1535 ambulance confirmed. 1540- Ambulance arrived. Turned over care to EMS
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| 46 | 2021-02-28 | heart rate increased |
Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consume...
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Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El9261) via an unspecified route of administration, on the left arm, on 22Jan2021 at 15:30 PM (at the age of 46 years) at a single dose for COVID-19 immunization. Medical history included Hashimoto's disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liothyronine (LIOTHYRONINE), thyroid (ARMOUR THYROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 16:30 PM, the patient experienced increased heart rate, over 100 when resting. The event was reported as non-serious. The patient had lab tests which included heart rate: over 100 on 22Jan2021. No treatment was given. The clinical outcome of the increased heart rate, over 100 when resting was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 46 | 2021-03-01 | fainting |
The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal s...
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The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
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| 46 | 2021-03-01 | vaginal haemorrhage |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-02 | palpitations, heart rate increased |
After injection, patient reported a racing heartbeat and onsite EMS was notified. Patient also had ...
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After injection, patient reported a racing heartbeat and onsite EMS was notified. Patient also had redness in back of throat. Given 50mg of Benadryl IM and transferred to ED.
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| 46 | 2021-03-02 | chest pain, chest discomfort | Chest burning and tightness and SOB. Gave albuterol neb and Benadryl. |
| 46 | 2021-03-03 | chest discomfort |
Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and ...
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Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and wheezing yesterday, she has a history of asthma. The chest tightness and wheezing increased after her vaccine. She also noted tingling to her lips and dizziness. She had no shortness of breath, cough, palpitations or chest pain. No angioedema, rash or pruritis. She was in no acute distress. She was talking in complete sentences and drinking water without any issues. Her lungs were clear through out with no bronchospasm, her heart rate was regular. BP 160/100, HR 66, RR 22, O2 99% on room air. I spoke with the RN at ICC who accepted patient to be seen at the ICC for further evaluation and monitoring. Patient declined ambulance transfer and felt comfortable enough to drive her self to the ICC. She was monitored at the vaccine clinic for 35 minutes after receiving her vaccine and left in stable condition. Her sister was notified.
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| 46 | 2021-03-04 | palpitations, chest discomfort |
Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-last...
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Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-lasted approx 15-20 minutes
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| 46 | 2021-03-05 | palpitations | Headache, blurry vision, heart palpitations, feeling off, eyes sore, eyes hurt, |
| 46 | 2021-03-06 | hypertension, fast heart rate |
reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, t...
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reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, tachycardia and high blood pressure I was given benadryl and when symptoms did not improve was taken to ER and given Decadron at 4:42pm then Famotidine and Sodium Chloride 0.9%
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| 46 | 2021-03-07 | chest discomfort |
Pt started feeling shortness of breath and chest tightness. Was give zyrtec, epipen 0.3 mg, and albu...
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Pt started feeling shortness of breath and chest tightness. Was give zyrtec, epipen 0.3 mg, and albuterol inhaler. Pt then reported feeling "phlegmy" and was then transported by EMS.
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| 46 | 2021-03-08 | lightheadedness, loss of consciousness |
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER...
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ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER. VASOVAGAL LIKELY.
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| 46 | 2021-03-09 | palpitations |
Heart palpitations, c/o nausea and dizziness. Employee taken to hospital ER. Epi given and prescript...
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Heart palpitations, c/o nausea and dizziness. Employee taken to hospital ER. Epi given and prescription for Benadryl
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| 46 | 2021-03-09 | inflammation of the heart muscle |
Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found t...
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Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis. She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21. She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory. As of this submission she has been transferred to the cardiac floor and seems to be recovering. Symptoms started ~14d after 1st dose COVID vaccine. She also had self limited COVID infection in early January, 2021.
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| 46 | 2021-03-09 | palpitations |
Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing h...
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Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing heart rate then episodes of chills and sweating. The next day I had a hard time holding my tooth brush, pain and swelling to both hands and severe pain in left foot. When I get up from sitting position to walking it feels like my bones in my left foot will shatter. The pain is very bad even in bed when I?m not moving.
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| 46 | 2021-03-09 | deep vein blood clot, chest pain, fibrin d dimer increased, chest discomfort, pulmonary embolism |
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ...
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got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
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| 46 | 2021-03-10 | fainting | Dizziness, syncope, evaluated by EMS-transported to nearest ER |
| 46 | 2021-03-11 | heart rate decreased, hypotension |
Patient c/o nausea and feeling sweaty after receiving vaccine. Symptoms included low HR and hypotens...
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Patient c/o nausea and feeling sweaty after receiving vaccine. Symptoms included low HR and hypotension.
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| 46 | 2021-03-12 | palpitations, blood pressure increased |
Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccina...
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Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccination site. Pt. taken to triage area and evaluated by MD. Pt. observed for an additional 30 min and then released to home. 1026- 166/117, Spo2 100%, p 72 1030- 144/105, 72 1032- pt states all symptoms have resolved. 1055- pt. released to home.
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| 46 | 2021-03-13 | fainting, palpitations |
pain in lower back that would move to the front starting 4 days after the shot. Dizziness, nausea, f...
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pain in lower back that would move to the front starting 4 days after the shot. Dizziness, nausea, faintness, lightheadedness, palpitation and feeling there is a cloud in my brain starting 4 days after
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| 46 | 2021-03-14 | hypertension |
PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. P...
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PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. PLACED ON STRETCHER PRIOR TO INJECTION. FIVE MINUTES AFTER INJECTION PT. C/O BEING HOT , FEELING "WEIRD" DENIED BREATHING DIFFICULTIES. EVALUATED BY EMTS, BP 180/120, HR 96, RR32 O2 SAT 100% ON RA. BP RETAKEN WITH MANUAL CUFF BY EMT REMAINED HIGH. PT. BP FOLLOWED FREQUENTLY OVER 30 MINUTES REMAINED ELEVATED TRANSPORTED TO ER BY AMBULANCE.
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| 46 | 2021-03-14 | blood pressure increased |
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw...
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Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
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| 46 | 2021-03-15 | heart rate increased |
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ...
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25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
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| 46 | 2021-03-15 | chest discomfort, chest pain |
Nausea, chest pain, tightness in throat 178/55 50mg Benadryl given IM. Pt stated improvement . Tran...
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Nausea, chest pain, tightness in throat 178/55 50mg Benadryl given IM. Pt stated improvement . Transported to ER
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| 46 | 2021-03-16 | chest discomfort, hypertension |
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines...
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Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
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| 46 | 2021-03-17 | heart rate increased |
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with sh...
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Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller. Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78 BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
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| 46 | 2021-03-18 | palpitations | Heart palpitations continued for 5-7 days after the shot. |
| 46 | 2021-03-18 | fainting |
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to...
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Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-20 | blood pressure increased |
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vacc...
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1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
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| 46 | 2021-03-21 | hypotension |
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv...
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10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
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| 46 | 2021-03-21 | chest discomfort | SOB, chest tightness, dizziness |
| 46 | 2021-03-21 | heart rate increased, blood pressure increased |
Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart ra...
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Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me Phenergan. I had a chest x-ray that didn't show anything unusual. I was then give Meclazine for the naseau and headache and a full bag of IV fluids. It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy. Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done. I had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine. I was referred to Otolarynology on 3/17/21. The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21. I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
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| 46 | 2021-03-21 | excessive bleeding, blood pressure decreased, inflammation of the heart muscle, blood clot, low platelet count |
severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card...
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severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
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| 46 | 2021-03-22 | heart rate increased |
After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that...
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After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that they felt a tingling sensation on their left arm that travel upwards as well. They felt their heartbeat a bit fast as well. Blood pressure was taken and it was at 148/92. No other event occurred; patient was able to leave a short time after.
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| 46 | 2021-03-22 | pallor |
Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilater...
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Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilateral dependent peripheral neuropathy in hands and feet. Bilateral ear tenderness.
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| 46 | 2021-03-22 | fainting, loss of consciousness |
I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended ...
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I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended up lose muscle control and urinated . Afterwards, I could not speak well. I continued to have massive headaches
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| 46 | 2021-03-22 | hypertension, chest discomfort, chest pain |
Sever hypertension. Up to 215/157, severe chest pain and tightness. I was put in the emergency room ...
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Sever hypertension. Up to 215/157, severe chest pain and tightness. I was put in the emergency room department. It took about 2 1/2 for my blood pressure to go down to normal range..
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| 46 | 2021-03-23 | chest discomfort |
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throa...
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About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room. Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related. My arm hurts quite a bit today but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
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| 46 | 2021-03-23 | fainting |
This was this person's second dose. She had episode of syncope following the first dose that require...
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This was this person's second dose. She had episode of syncope following the first dose that required prolonged monitoring in the EC. Patient was laid down on stretcher prior to vaccine administration. Patient immediately went syncopal following injection and became unresponsive. Breathing remained even and nonlabored with good pulse. Patient remained lying down for about 30 minutes before she sat in a chair for approximately 15 minutes. Attempt to have patient leave but patient became syncopal again in bathroom and needed to be assisted into wheelchair and brought back to observation area where she laid down for another 15 minutes. Patient was alternating back and forth between being alert and unresponsive. Patient was finally able to leave area with mother at 1719. Refused to be transferred to the Emergency Room for evaluation.
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| 46 | 2021-03-23 | heart rate increased, blood pressure increased, chest discomfort, palpitations |
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight...
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Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
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| 46 | 2021-03-23 | chest discomfort | itching tightness in chest |
| 46 | 2021-03-24 | chest discomfort |
Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 4...
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Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 48 hours after shot. Slight throat scratchiness and tight chest and asthma flair up.
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| 46 | 2021-03-24 | pulmonary embolism |
Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of...
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Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of 1 week
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| 46 | 2021-03-24 | heart rate increased |
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes...
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Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
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| 46 | 2021-03-24 | blood pressure increased, fast heart rate |
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu...
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congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
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| 46 | 2021-03-24 | heart rate increased |
during counseling before the shot and reviewing her consent form she stated she had a reaction to a ...
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during counseling before the shot and reviewing her consent form she stated she had a reaction to a flu shot when she was a baby but has not had any reactions to vaccines since-she does not get a yearly flu shot but other vaccines were stated as no incident. she received the shot without incident and sat with me for a few minutes in the counseling room and was fine. several minutes after that she told one of my technicians who was leaving the pharmacy she was going to pass out. we laid her down on the floor and proceeded to call 911. she said her heart rate was up and she self monitored with her apple watch. she never lost consciousness and was ok when the ems arrived. she chose not to go with ems and left with her husband who had been called.
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| 46 | 2021-03-25 | palpitations |
3-24-21 6:20PM PT STATES SHE FEELS LIGHTHEADED, SWEATY, HEART RACING'. STATES SHE IS 'NERVOUS ABOUT ...
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3-24-21 6:20PM PT STATES SHE FEELS LIGHTHEADED, SWEATY, HEART RACING'. STATES SHE IS 'NERVOUS ABOUT GETTING SHOT AND WAITED AN EXTRA HALF HR' AFTER HER WAIT TIME. A/O, PINK, W/D, RESP WITH EASE. 6:25PM PT STATES SHE 'FEELS BETTER'. HUSBAND HERE TO DRIVE PT HOME. GAIT BRISK AND STEADY.
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| 46 | 2021-03-25 | heart rate increased |
After receiving vaccination patient c/o rapid HR and chills. Vital signs taken BP 155/92, HR 118. Re...
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After receiving vaccination patient c/o rapid HR and chills. Vital signs taken BP 155/92, HR 118. Reported not having anything to eat or drink this am prior to administration. Vitals monitored in total 40 minutes. Chills now resolved. HR 77 and BP 147/83 prior to departure. Offered option to be checked out in ED here at medical center. Patient declined. Given water, oj, and pastry per request. Denied itching, rash, or swelling of any kind prior to departure. Followed up with patient 3/26/21 at 1248 via number listed. Stated her symptoms had resolved and not returned after leaving medical center. No new symptoms reported. Discussed severe allergic reaction s/s and to go to nearest ED should they occur.
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| 46 | 2021-03-25 | chest discomfort |
Delayed onset chest tightness with SOB - took own albuterol 2 puffs with resolution. No airway invol...
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Delayed onset chest tightness with SOB - took own albuterol 2 puffs with resolution. No airway involvement. Normal pulse, oxygen and BP
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| 46 | 2021-03-25 | heart rate increased |
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi...
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Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
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| 46 | 2021-03-25 | heart attack, heart attack | Vaccine administered 12/31/20. SCAD heart attack on 01/21/21. |
| 46 | 2021-03-26 | fainting | Syncopal episode after receiving vaccine. |
| 46 | 2021-03-27 | blood pressure increased, fainting |
Syncopal episode. ALS assessment completed . with Sinus on Monitor. Noted elevated BP with Sugar of ...
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Syncopal episode. ALS assessment completed . with Sinus on Monitor. Noted elevated BP with Sugar of 97. Refused transport to the Hospital and signed refusal . Vitals signs set #1 175/97, 90 18, Pulse Ox 100%, Set 2 182/20, 84 18, 100%, Set 3 171/83, 82, 18 100%
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| 46 | 2021-03-27 | palpitations | heart racing, palpitations, shortness of breath, hot flashes |
| 46 | 2021-03-28 | hypertension, body temperature decreased, loss of consciousness |
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost pass...
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The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date. The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported. The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
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| 46 | 2021-03-30 | fainting |
felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy;...
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felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 17Mar2021 10:45 (Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication was reported as none. The patient previously had BNT162B2 first dose lot number: EL3247 on 24Feb2021 10:00 AM, in left arm for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 20:30, the patient experienced chills, shivers, cold sweating, felt very faint and weak and extreme lethargy. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.
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| 46 | 2021-03-30 | blood pressure increased |
increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from...
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increased blood pressure; reddening of the skin all over her body; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021027233). This case was split from master case #2021218108 to capture a 46-year-old female patient taking BNT162B2 and experienced increased blood pressure and skin red. This non-serious solicited report (USASL2021027233) was reported on 18/FEB/2021 by a consumer from a commercial program (PSP00086) and involves a 46 years old female patient who experienced increased blood pressure/blood pressure has continued to be elevated 180/100 [PT: blood pressure increased], migraines [PT: migraine] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, increased blood pressure, reddening of the skin all over her body. It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. On 28/JAN/2021, the patient's blood pressure has continued to be elevated 180/100, even with Enbrel medication. Additionally, on an unknown date in JAN/2021, the patient had migraines and possible fibromyalgia. No treatment information was received. The outcome of the event blood pressure increased was reported as not recovered/not resolved. The outcome of the event migraine was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was continued for the event blood pressure increased. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the event migraine. The causal relationship between the events blood pressure increased, migraine and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. Follow-up (08Mar2021): The following information was received: Narrative states, It was further mentioned that on 08/JAN/2021, the patient had a Covid vaccine and had a reaction to it immediately that including increased blood pressure and reddening of the skin all over her body. Kindly confirm Covid vaccine is co-suspect or concomitant. Response: As per the information in the case: 08/JAN/2021, the patient had a Covid vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on 28/JAN/2021. Therefore, the Covid vaccine which was prior to Enbrel start is neither considered as co-suspect nor concomitant medication. The company is performing due diligence, and should further information be received, the case will be updated accordingly. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 46 | 2021-04-03 | nosebleed, chest pain |
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S...
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She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
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| 46 | 2021-04-05 | low platelet count | Thrombocytopenia Now 2 aneurism in brain Angio scheduled for 4/14/21 |
| 46 | 2021-04-06 | loss of consciousness, fainting |
patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in he...
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patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in her pants; Felt dizzy after 12 hours; patient had problems with concentrating; massive headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (lot number: 1; pending clarification) at the age of 46 years old, as single dose for covid-19 immunization. Medical history included allergy to metals (titanium metal). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Mar2021 21:00, the patient experienced massive headache. After 12 hours (09Mar2021 21:30), the patient felt dizzy. On 10Mar2021, around 10 am, the patient fainted as lost consciousness, urinated in her pants and had problems with concentrating. No treatment was given for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient was recovering from all the events.
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| 46 | 2021-04-07 | hypertension |
atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventuall...
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atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventually sensation of swelling in her throat within 60 minutes. There were no other secondary systemic/organs affected apart from mild transient hypertension. Given the strong concern for subjective airway compromise, I directed the administration of epi which the patient said she felt her throat relax after adminstration. 911 was called and patient was transported to ED.
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| 46 | 2021-04-08 | pulmonary embolism | I was diagnosed with a pulmonary embolism on 1/15/21 |
| 46 | 2021-04-10 | ischemic chest pain, chest pain |
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig...
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7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
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| 46 | 2021-04-12 | deep vein blood clot |
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at...
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DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
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| 46 | 2021-04-12 | pulmonary embolism, troponin increased, fibrin d dimer increased, chest pain, fast heart rate |
Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had ...
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Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea.
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| 46 | 2021-04-12 | pulmonary embolism |
Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on...
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Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
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| 46 | 2021-04-12 | heart rate increased |
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This i...
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overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-04-12 | hypertension |
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla...
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skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-13 | heart rate increased, chest pain, hypertension, palpitations |
High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest...
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High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest pain. Heart palpitations. Welt at injection site, was painful and itchy. Stomach cramping and loose stool.
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| 46 | 2021-04-13 | atrial fibrillation, cardiac arrest | a fib and cardiac arrest |
| 46 | 2021-04-13 | pulmonary embolism, chest pain | patient developed chest pain, right rib pain and dyspnea 1 day following vaccine |
| 46 | 2021-04-15 | heart attack |
Patient presented to Hospital with an anterior wall myocardial infarction 5 days after second Pfizer...
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Patient presented to Hospital with an anterior wall myocardial infarction 5 days after second Pfizer COVID19 vaccine. She was fully anticoagulated with Warfarin at the time of presentation. No prior cardiac history. She was treated with primary PCI of the LAD.
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| 46 | 2021-04-15 | loss of consciousness |
Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, an...
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Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, and pt had intermittent loss of consciousness. Maintained pt in a comfortable position until EMS arrived. BP 193/130, HR 124, O2 99%, RR 14.
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| 46 | 2021-04-15 | palpitations, chest discomfort, fast heart rate |
Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my ...
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Slightly blurry vision in 15 minutes. Then at the 31 minute mark, my throat started swelling and my chest was tight, so it was hard to catch my breath. My whole face and ears turned red and i was itchy on my arms. 2 doses of Benadryl made the allergic reaction ease. I was tired for the next two weeks, and then started having heart palpitations regularly. Went to ER was diagnosed with Tachycardia, Hyperkalemia, Hypomagnesemia, and Hypocalcemiaand. Corrected with intravenous drugs and overnight stay in the hospital. Slowing feeling some better, but struggling with inflammation and being exhausted. Felt 100% great before getting this vaccine. Advised by doctors not to get second shot and did not get it.
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| 46 | 2021-04-17 | pulmonary embolism |
On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing p...
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On Monday 4/5/21 I received 1st dose of Pfizer vaccine. On Wednesday 4/7/21 I started experiencing pain in my abdominal upper right side and had difficulty breathing. Thursday 4/8/21 the symptoms worsened so Friday morning 4/9/21 I went to the Urgent Care and they sent me to the hospital ER. Friday evening 4/9/21 I have been admitted to the hospital with pulmonary embolism! I was realesed from hospital on Sunday 4/11/21. I am currently taking Warfarin & Enoxaparin injections.
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| 46 | 2021-04-20 | chest discomfort |
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an...
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Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
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| 46 | 2021-04-20 | loss of consciousness |
passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy o...
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passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.
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| 46 | 2021-04-24 | heart rate increased, fainting, hypertension |
fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was ve...
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fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was very high; fast heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration, administered in arm left on 27Mar2021 18:15 (at the age of 46-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. No other medication in two weeks. No other vaccine in four weeks. On 27Mar2021 18:45, the patient felt weak and dizzy a few minutes after getting the vaccine and then she fainted. The paramedics took her to the ambulance to check her vitals. EKG, blood sugar and blood oxygen was good, but her blood pressure was very high. Clinical course details was reported as she received the first dose of the Pfizer COVID vaccine on 27Mar2021 and she experienced fainting, dizziness, weakness and a fast heartbeat. The patient would like to know if fainting was considered an allergic reaction. The patient would like to know if she should receive the second dose of the vaccine. She received the 1st dose last 27Mar2021 and 2nd dose will be on 17Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was recovering. The patient did not covid tested post vaccination.
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| 46 | 2021-04-26 | deep vein blood clot, blood clot |
Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the ho...
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Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work. The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.
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| 46 | 2021-04-26 | chest discomfort |
Going on week two continued difficulty breathing. I have been doing breathing treatments and inhaler...
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Going on week two continued difficulty breathing. I have been doing breathing treatments and inhaler. Dry cough, some wheezing, some tightness in chest at times when breathing is harder.
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| 46 | 2021-04-28 | pulmonary embolism |
pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous...
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pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
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| 46 | 2021-05-02 | hypertension |
A few minutes after the vaccine was administered, I started to feel dizzy, my blood pressure went up...
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A few minutes after the vaccine was administered, I started to feel dizzy, my blood pressure went up to 168, they had to transfer me to the hospital by ambulance, after that I had diarrhea for a week, fever for several days. body aches and chills.
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| 46 | 2021-05-04 | palpitations, heart rate increased, chest pain |
12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted ab...
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12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted about 5 min, after which my muscles started rapidly twitching all over body. Muscles are twitching every few seconds, I am having multiple muscle cramps at random times, sharp intermittent pain all over body. I started having frequent tremors in my hands, muscles feel strained and it is difficult to walk or perform on the piano (my job). 2 days ago I started experiencing constant pins and needles all over my body. My pulse is in the 80s (normally in the 60s), I feel frequent heart palpitations.
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| 46 | 2021-05-04 | fainting, loss of consciousness |
Experienced syncope approximately a half hour after getting out of bed; Passed out on kitchen floor;...
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Experienced syncope approximately a half hour after getting out of bed; Passed out on kitchen floor; Dizziness episode lasted for approximately an hour, of which half was spent on the floor.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), via an unspecified route of administration, administered in arm left on 19Apr2021 17:00 (Batch/Lot Number: EW0164) as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing as it was reported that the patient had covid prior vaccination. The patient's concomitant medications were not reported. The patient had not been given any other vaccine in four weeks prior to covid vaccine. The patient was not pregnant. On 20Apr2021 12:15 PM, the patient experienced syncope approximately a half hour after getting out of bed. She passed out on kitchen floor. Dizziness episode lasted for approximately an hour, of which half was spent on the floor. The outcome of 'Experienced syncope approximately a half hour after getting out of bed' and 'Passed out on kitchen floor' was recovering while Dizziness was recovered on 20Apr2021 13:15 (lasted for approximately an hour). No treatment received for the events. The patient had not been tested for covid post vaccination.
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| 46 | 2021-05-04 | chest discomfort, loss of consciousness, lightheadedness, chest pain |
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency...
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Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-05-07 | blood clot |
Two large hot swollen areas on right leg Went to ER ultrasound detected superficial clot; This is a ...
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Two large hot swollen areas on right leg Went to ER ultrasound detected superficial clot; This is a spontaneous report from a contactable consumer (patient). This 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 19Apr2021 12:15 (Batch/Lot Number: EWO164) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA), and ibuprofen. The patient previously took tobramycin and Wellbutrin and experienced allergies for both. Patient received the first dose of bnt162b2 for COVID-19 immunization on an unspecified date (lot number unknown). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 20Apr2021 18:30, patient had two large hot swollen areas on right leg. She went to the ER. Ultrasound detected superficial clot. AE resulted in emergency room/department or urgent care. Patient has not recovered from the event. Treatment included antibiotics and ibuprofen.
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| 46 | 2021-05-10 | blood pressure increased, heart rate increased |
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;...
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had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
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| 47 | 2021-01-02 | chest discomfort, oxygen saturation decreased |
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST...
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BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
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| 47 | 2021-01-03 | palpitations |
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m...
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12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
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| 47 | 2021-01-03 | heart rate increased | EE presented to EH with c/o hives to face and racing heart rate at 1445 |
| 47 | 2021-01-04 | chest discomfort |
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea...
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Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
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| 47 | 2021-01-04 | heart rate increased | high heart rate, blotchy/flushed skin, urticaria |
| 47 | 2021-01-05 | chest discomfort |
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain...
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Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
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| 47 | 2021-01-05 | heart rate increased, blood glucose increased |
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w...
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Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
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| 47 | 2021-01-05 | chest pain, chest discomfort |
Rec'd Covid vaccine 10 minutes afterwards, employee stated she felt weird in her chest, states she d...
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Rec'd Covid vaccine 10 minutes afterwards, employee stated she felt weird in her chest, states she didn't know if it was anxiety, state pain 4/.10 offered employee to be evaluated - refused requested to sit and be monitored BP 132/72, HR 71 POX 98% repeat vs employee states chest tight refused ED eval and RRT B/P 137/77 HR 70 POX 98% still refusing ED state just wants to be monitored for a few minutes 1745 BP 140/79 HR 70 POX 98% final VS at 1751 129/77, HR 70 POX 99% Employee states she feels more comfortable now and is ready to go home. She further states she knows what to do.
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| 47 | 2021-01-06 | hypertension | Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm |
| 47 | 2021-01-06 | fast heart rate |
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ...
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Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
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| 47 | 2021-01-07 | chest pain |
Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating j...
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Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
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| 47 | 2021-01-07 | blood pressure increased |
Patient developed headache almost immediately after vaccine administration that persisted with sligh...
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Patient developed headache almost immediately after vaccine administration that persisted with slight worsening. Her BP was found to be elevated 4 hours later to 180s/100s; on manual recheck, was 172/96. Given signs and symptoms consistent with hypertensive urgency, she was sent to the emergency room. She has a history of well-controlled HTN and has been adherent to her medications (including the day of vaccine administration); she has had no recent episodes of uncontrolled BP.
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| 47 | 2021-01-07 | chest discomfort |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | heart rate increased |
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breat...
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noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
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| 47 | 2021-01-08 | chest pain |
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left...
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1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
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| 47 | 2021-01-08 | heart rate increased |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-08 | ischemic chest pain | Dizziness & Angina Narrative: |
| 47 | 2021-01-10 | hypotension, fast heart rate |
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ...
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3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
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| 47 | 2021-01-10 | hypertension |
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to...
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? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
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| 47 | 2021-01-10 | hypotension |
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head...
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Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
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| 47 | 2021-01-10 | blood pressure decreased, heart rate increased, fast heart rate |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | fast heart rate |
Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal ...
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Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal sensation in the back of my tongue. This lasted for about 20-25 minutes and then mostly resolved. I was monitored by the paramedics. I had normal vitals at the time of evaluation which was soon after notifying staff. After the 1st injection I had a similar episode, but I thought it was anxiety related.
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| 47 | 2021-01-10 | palpitations | headache, fever, palpitations |
| 47 | 2021-01-11 | fast heart rate, chest discomfort |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | chest discomfort |
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of...
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Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
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| 47 | 2021-01-11 | chest pain |
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later...
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Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
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| 47 | 2021-01-11 | heart rate increased |
Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own wit...
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Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own within 10 - 15 minutes; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at left arm, on 19Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included myasthenia gravis, allergy to IV contrast used for CT scans. Concomitant medication included pyridostigmine bromide (MESTINON), melatonin, ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within a few minutes of the vaccine, on 19Dec2020 13:00, the patient felt a sudden increase in heart rate (HR) and resolved on its own within 10 to 15 minutes on 19Dec2020. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
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| 47 | 2021-01-12 | blood pressure increased |
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving...
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Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
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| 47 | 2021-01-12 | chest pain |
Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unr...
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Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unremarkable. Cardiologist to follow up.
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| 47 | 2021-01-12 | blood pressure decreased, lightheadedness, pallor, fast heart rate, heart rate increased |
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ...
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feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
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| 47 | 2021-01-13 | fast heart rate |
Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathi...
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Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathing/shortness of breath but pt states it may be associated with the mask.
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| 47 | 2021-01-13 | hypertension |
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; sy...
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Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
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| 47 | 2021-01-13 | heart rate increased |
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms las...
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Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
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| 47 | 2021-01-14 | fast heart rate |
Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. ...
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Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. Symptoms passed after 10 minutes of observation. Sent patient home per her request.
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| 47 | 2021-01-14 | chest pain |
Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Report...
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Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Reports red solid rash in both armpits and a quarter sized red patch at the injection site. Notes One instance of diarrhea.
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| 47 | 2021-01-14 | palpitations |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-15 | fainting, fast heart rate, hypertension |
1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near sync...
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1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near syncope episode with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present until next morning. 17 hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
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| 47 | 2021-01-15 | heart rate decreased, palpitations |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-15 | chest discomfort |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-15 | heart rate increased |
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin...
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Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
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| 47 | 2021-01-16 | heart rate increased |
Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left ...
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Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left shoulder. Most symptoms lasted 36 hrs, nausea and fatuge lasted 48 hrs
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| 47 | 2021-01-17 | heart rate increased |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-18 | palpitations, chest discomfort |
Started to have palpitations with some dizziness prior to second dose of the vaccine on 1/10/21, a...
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Started to have palpitations with some dizziness prior to second dose of the vaccine on 1/10/21, and then night of vaccine 1/11/2021, had chest pressure and palpitations. On 1/12 had worse symptoms , on 1/13 still had those symptoms but less. Came back to work on 1/14 and same symptoms . Came to ED on 1/13/21 had full work up neg EKG, neg CT scan, neg labs. Has Holter now. ( H/O covid in April 2020 had chest pressure when had covid. ) needs to follow up with PCP. No other PMH
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| 47 | 2021-01-18 | fast heart rate | Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever |
| 47 | 2021-01-18 | vaginal haemorrhage |
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we...
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fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
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| 47 | 2021-01-19 | heart rate decreased |
I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt...
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I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt lightheaded and like I was going to pass out. After a bit I felt a little better but remained dizzy and lightheaded. On the 7th I continued to feel dizzy and lightheaded throughout the day. I was sitting down on a call in the afternoon when my Apple watch vibrated and indicated my heart rate was below 50 for 10 minutes. I checked my heart rate and it was 38 - 48 BPM. On the morning of the 8th I reported my persistent symptoms to Dr. and an EKG was done showing a heart block. I have had bradycardia for the past year and likely the heart block but was not symptomatic until after I took the vaccine. See next pg
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| 47 | 2021-01-20 | chest discomfort, chest pain, palpitations, fast heart rate |
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm s...
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I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches. On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20. On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain. On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive. They also tested me for strep and flu, both were negative. I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain. I am a RN and monitored my O2 Sats and HR frequently. My symptoms finally resolved enough for me to return to work on 1/11/21.
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| 47 | 2021-01-20 | palpitations |
weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, describe...
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weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, described her left leg veins appeared transiently engorged soon after 1st dose of pfizer covid vaccine
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| 47 | 2021-01-22 | lightheadedness | Anaphylaxis with shortness of breath, throat tightness, dizziness and wheezing with near syncope. |
| 47 | 2021-01-24 | fast heart rate, chest discomfort |
12 hours after my injection, by temperature shot up to 103. I experienced tachycardia with my pulse...
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12 hours after my injection, by temperature shot up to 103. I experienced tachycardia with my pulse ranging from 130-140. My heart rate went even higher. My normal pulse range is 60-70. My resting heart rate is range is 50-60. Additionally, I experienced chest pressure, chills. I'm still experiencing sudden burst of tachycardia and chest pressure today, seven days after my vaccine.
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| 47 | 2021-01-24 | chest pain | Dizziness and Chest pain-- > ER |
| 47 | 2021-01-24 | chest discomfort, chest pain |
Injection administered at 7:39 am. Immediate sense of relaxation during post injection. 2-3 hours la...
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Injection administered at 7:39 am. Immediate sense of relaxation during post injection. 2-3 hours later experienced some lightheadedness and tiredness, by 3pm experienced chest tightness and burning, difficulty breathing, coughing, fatigue. Used my nebulizer every 4 hrs. Used rescue inhaler as needed Ventolin symptoms improved. 1/24/21 symptoms improved. Experienced some coughing and shortness of breath not as significant as day of vaccine. Recovery continues.
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| 47 | 2021-01-25 | hypertension | Hypertension and headache within minutes of vaccination; symptoms resolved by 20-30 minutes |
| 47 | 2021-01-25 | fast heart rate | Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg |
| 47 | 2021-01-26 | blood clot |
Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she ...
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Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she began bleeding again after receiving her second dose and that it was a heavy and clotted cycle. She was advised to contact her OB/GYN
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| 47 | 2021-01-26 | palpitations | Flushing, heart racing, itching in fingers |
| 47 | 2021-01-26 | chest discomfort |
She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report fr...
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She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable 47-year-old female Consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she is now feeling little congestion like sinus and tightness in chest in Jan2021 with outcome of unknown. She was not sure if it's from the vaccine. No treatment was received. The patient underwent lab tests and procedures which included weight: was like 200 pounds lbs on an unknown date. information on the batch/lot number has been requested.
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| 47 | 2021-01-27 | blood pressure decreased |
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple h...
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Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
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| 47 | 2021-01-27 | chest pain |
Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration...
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Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration. Also complains of sharp chest pain. VS-152/92, 92, 24, 99% on RA. Advised to go to ER for further evaluation. Spouse came and picked patient up and took to the ER she did not want to go via ambulance.
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| 47 | 2021-01-28 | heart rate increased |
Chills; sweats; rapid pulse; temp; This is a spontaneous report from a contactable other health prof...
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Chills; sweats; rapid pulse; temp; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Jan2021 11:30 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant at the time of vaccination. Medical history included diagnosed with covid-19 from an unknown date. Patient tested for COVID-19 (Nasal Swab) on 11Jan2021, the result was negative. Concomitant medication included escitalopram oxalate (LEXAPRO), vitamin d [vitamin d nos] (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C). No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills, sweats, rapid pulse, temp on 16Jan2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Since the vaccination in Jan2021, patient has been tested for COVID-19, the result was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.
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| 47 | 2021-01-28 | chest pain, chest discomfort |
Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with h...
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Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with hospital grade temporal thermometer. Pulse rate of 140 and POX of 96. At 07:23 took 650mg Tylenol and 50mg oral diphenhydramine with 16 oz water. Chest tightness subsided around 10 minute mark and shaking stopped after one hour. Sleep from 10:00-16:00. Woke up with a headache and mental confusion.
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| 47 | 2021-01-28 | body temperature decreased |
ears have been burning; she checked her temperature and it is lower than normal, her temperature is ...
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ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
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| 47 | 2021-01-29 | chest discomfort, chest pain |
Chest pain and discomfort with inhaling, nausea and leg fatigue. Happened 3 days post vaccine. No in...
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Chest pain and discomfort with inhaling, nausea and leg fatigue. Happened 3 days post vaccine. No injection site pain
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| 47 | 2021-01-30 | platelet count decreased |
Patient developed large, hard, nonpainful thyroid nodule. Workup is still ongoing, but TSH and CRP n...
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Patient developed large, hard, nonpainful thyroid nodule. Workup is still ongoing, but TSH and CRP normal. Ultrasound is reassuring for malignancy. Date of adverse effect is the date she noticed it, but it is large enough that she couldn't have missed it more for than a day or two. I'm not sure that this WAS an adverse effect, but the timing seemed necessary for reporting.
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| 47 | 2021-01-31 | chest pain | Chest pain. Upper back pain, jaw pain, pain in opposite arm |
| 47 | 2021-01-31 | nosebleed |
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ...
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Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
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| 47 | 2021-01-31 | fast heart rate |
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ...
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my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-01 | blood pressure increased, heart rate increased |
5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased t...
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5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased to 150/90. I felt weird, almost like I was under water. I remained under observation for 45 minutes. I was sent home and told to continue monitoring myself and to come back if I get worse.
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| 47 | 2021-02-01 | chest pain |
Moderate pain at site x 1 day, short intermittent sharp pain in chest, nausea; left side facial sens...
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Moderate pain at site x 1 day, short intermittent sharp pain in chest, nausea; left side facial sensitivity to touch and cold, nausea, and diarrhea
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| 47 | 2021-02-01 | hypertension, palpitations |
discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my l...
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discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown. Information about lot/batch number has been requested.
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| 47 | 2021-02-01 | heart rate increased, palpitations |
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from...
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throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-03 | chest discomfort, chest pain, heart rate abnormal, palpitations |
Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai...
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Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
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| 47 | 2021-02-03 | hypertension | Itchy, lightheaded, high blood pressure, seeing stars, diarrhea |
| 47 | 2021-02-03 | palpitations |
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heav...
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Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
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| 47 | 2021-02-03 | palpitations |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | hypertension |
Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse...
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Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 11Jan2021 07:15 for Covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included allergy to beer. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications patient received within 2 weeks of vaccination. The patient experienced sudden onset of hypertension (without history) on 12Jan2021 06:00. Event required doctor or other healthcare professional office/clinic visit. The event was considered as non-serious by the reporter. Treatment received for the adverse event included oral lisinopril 10 mg. Nasal swab (PCR) on 18Jan2021 was negative. The patient had not recovered from sudden onset of hypertension at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
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| 47 | 2021-02-03 | hypertension |
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu...
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Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
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| 47 | 2021-02-04 | blood pressure increased |
getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from ...
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getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-02-06 | chest discomfort, palpitations |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-07 | palpitations |
Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pul...
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Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pulse felt normal approx. 80bpm. Left foot was tingly. Wheelchaired to Emergency Room.
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| 47 | 2021-02-07 | palpitations |
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe...
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Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
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| 47 | 2021-02-08 | blood pressure increased, heart rate increased, chest discomfort |
1:30 pm EE felt woozy "doesn't feel right" HR 120 1:35 pm Throat felt ? HR 140 BP 130/60 SPO2 99% 1:...
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1:30 pm EE felt woozy "doesn't feel right" HR 120 1:35 pm Throat felt ? HR 140 BP 130/60 SPO2 99% 1:40 pm Chest tightness HR 118 BP 146/67 SPO2 100% 1:48 pm Benadryl given po at 1:45pm HR 100 BP 127/68 SPO2 100% 1:55 pm HR 100 BP 125/68 SPO2 100% 2:00 pm HR 102 BP 122/67 SPO2 100% 2:05 pm "Feeling OK" HR 96 BP 125/66 SPO2 98% 2:15 pm HR 99 BP 121/64 SPO2 100%
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| 47 | 2021-02-08 | chest discomfort | Hives, chest tightness, sinus drainage, and pressure |
| 47 | 2021-02-08 | fainting, palpitations |
Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by u...
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Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by urgent care and doctors. Wearing heart halter monitor. Symptoms have not gone away. Insomnia worse. Started 12 hours after vaccine. All labs normal 5 days before and all labs normal now., but still having symptoms. Missing work.
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| 47 | 2021-02-08 | hypertension | high blood pressure, dizziness, numbness of leg |
| 47 | 2021-02-09 | heart rate increased |
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ...
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Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-09 | fainting, hypertension | Systemic: Fainting-Medium, Systemic: Other- High BP |
| 47 | 2021-02-10 | blood pressure increased |
My blood pressure which has been stable became elevated. I experienced severe headache for a full da...
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My blood pressure which has been stable became elevated. I experienced severe headache for a full day, a little blurred vision, bp 160s / 100s. My bp remained elevated for several days, is normal today at last check. I saw my primary care provider yesterday and we are monitoring things for a week to see if this passes. If not further testing or medication adjustments may be needed.
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| 47 | 2021-02-14 | fainting |
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours...
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syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-15 | fast heart rate, oxygen saturation decreased, heart rate increased |
Approximately 12 hours after I received the injection, I started to experience muscle and joint pain...
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Approximately 12 hours after I received the injection, I started to experience muscle and joint pain. Soon after the pain started, I began feeling short of breath and feverish. Vitals were checked and I did not have a fever, but heart rate was elevated and oxygen saturation was low. Around 9:00 am, I began having restless leg symptoms in addition to other symptoms. I took oral Benadryl around 10:00 am and restless leg, tachycardia and low oxygen saturation began to subside. Muscle/joint pain and exhaustion continued for a couple days.
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| 47 | 2021-02-16 | heart rate increased |
shortness of breath and rapid heart rate that would not resolve in greater than 20 minutes of observ...
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shortness of breath and rapid heart rate that would not resolve in greater than 20 minutes of observing and oxygen
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| 47 | 2021-02-18 | blood pressure increased |
12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not ...
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12 pm felt woozy and mild headache and blood pressure spiked 4 pm nauseous and woozy something not right headache got worse 6pm arm started to hurt, headache got worse and so did nausea 10 pm whole body started to ache and chills with major headache and throwing up 4am next day 17th pain through whole body and headache so bad I was dizzy throw in up still 17th hard to walk from total body pain and headache 18th and 19 terrible headache pressure on whole head and neck can?t move neck. Eye pressures
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| 47 | 2021-02-18 | fainting | Pt had hives, syncopal episode, and airway management issues within 30 minutes of receiving vaccine. |
| 47 | 2021-02-21 | heart rate increased |
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron...
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About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
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| 47 | 2021-02-21 | palpitations |
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an...
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Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
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| 47 | 2021-02-21 | chest pain |
Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest p...
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Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.
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| 47 | 2021-02-22 | fast heart rate | Tachycardia,fever,malaise,fatiuge,headache,congestion, inflamed thyroid |
| 47 | 2021-02-23 | heart rate increased |
Heart rate spiked after vaccine. Received shot at 4:30pm. At 4:45 was cleared to leave and left the ...
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Heart rate spiked after vaccine. Received shot at 4:30pm. At 4:45 was cleared to leave and left the vaccine facility. At 4:56, the heart rate monitor on my watch alerted me to an abnormally high heart rate of 153. It went up to 155 before gradually returning to my normal heart rate of around 55. The spike and return to normal happened over the course of about 10 minutes. No shortness of breath or other symptoms to report.
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| 47 | 2021-02-23 | heart rate increased |
Immediately post vaccination patient complained of heart rate increase to the high 90's, low 100's. ...
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Immediately post vaccination patient complained of heart rate increase to the high 90's, low 100's. Patient waited an additional 15 minutes and heart rate normalized back to the 80's.
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| 47 | 2021-02-25 | blood pressure increased |
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Betw...
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Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
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| 47 | 2021-02-25 | fainting |
Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a p...
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Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-28 | chest discomfort |
After receiving her vaccine, client complained of itchy throat, tightness of chest and throat. Vita...
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After receiving her vaccine, client complained of itchy throat, tightness of chest and throat. Vital signs obtained B/P 151/98, HR 80, O2 sat 100%.
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| 47 | 2021-02-28 | heart rate increased, blood pressure increased |
At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping...
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At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping and soreness. Went to ER for this was perscribed naproxen for inflammation. Still nothing helped. Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker. I just want the pain and muscle cramps to stop. I hurt from head to toe.
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| 47 | 2021-02-28 | chest discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported chest tightness during observation ...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported chest tightness during observation period. Vaccine recipient was monitored by EMS. No further intervention needed.
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| 47 | 2021-02-28 | chest discomfort | Throat tightness, chest tightness-cleared by EMS |
| 47 | 2021-03-01 | chest discomfort | SWELLING IN THROAT "FEELS TIGHT", PRESSURE IN CHEST, COUGH. EVALUATED BY EMS-CLEARED |
| 47 | 2021-03-02 | heart rate increased | Chills, rapid Heart beat, weakness, fever |
| 47 | 2021-03-02 | palpitations | Palpitations, throat tightness. Evaluated by EMS-Cleared |
| 47 | 2021-03-02 | chest pain |
extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to...
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extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to 103 with alternating Tylenol and Ibuprofen, body aches, lasted 3 days
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| 47 | 2021-03-02 | chest discomfort, fast heart rate, blood pressure increased |
paramedic called for a 47 female here for first covid vaccination. no prior h/o reaction to other va...
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paramedic called for a 47 female here for first covid vaccination. no prior h/o reaction to other vaccines . pt followed by cardiology for unknown congential heart condition c/b episodes of tachycardia s/p "stress test " a few weeks but unable to complete the stress test. pt pt denies meds for her cardiac condition . approx 9 min after covid vaccine pt c/o substernal "indigestion type" chest tightness a/w sweating and globus sensation of the throat. pt did not have rash or hives or flushing or angioedema or shortness of breath or wheezing or dysphonia or stidor. exam pulse 84 bp 177/112 r 18 afeb pt did not appear in distress heent no angioedema cor rrr without murmur or gallop chest clr p&a. pt refused epinephrine but accepted oxygen. clinic did not have an ekg to assess cardiac status. but emt rhythm strip showed sinus tachycardia. pt transported ED without any medication intervention by emt
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| 47 | 2021-03-03 | chest pain |
Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia....
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Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia. Throughout the next day (1/13/21), I continued to have headache, body aches, and malaise as well as objective fever (up to about 101.5 degrees F), fatigue, dyspnea on exertion and lightheadedness. Later in the day (about 5:00pm) I developed significant shortness of breath at rest and chest pain. Later that evening I went to the Emergency Department because of concern over my extreme and persistent shortness of breath and chest pain. In the E.D. they did the following tests: EKG (normal), oximetry (normal), Portable Chest Xray (normal), rapid COVID test (normal), cardiac enzymes (normal), D-DIMER (ELEVATED), other bloodwork (normal). Because of the elevated D-dimer, a CT angiogram of the chest was performed to rule-out pulmonary embolism. The CT showed enlarged lymph nodes, but no evidence of pulmonary embolism. I was discharged home. By the next morning (1/14/21) I was feeling much better. And by the afternoon of 1/14/21 I was feeling completely back to normal without any symptoms.
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| 47 | 2021-03-03 | vaginal haemorrhage |
Pt reports menstruating during the first Covid vaccine on 1/19/21 and experiencing an increase in va...
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Pt reports menstruating during the first Covid vaccine on 1/19/21 and experiencing an increase in vaginal bleeding for 24 hours requiring changing a tampon every 30 min for 24 hours Pt reports not menstruating at the time of the 2 nd covid vaccine 2/8/21 but experiencing heavy vaginal bleeding for 24 hours
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| 47 | 2021-03-03 | palpitations, fast heart rate |
Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it we...
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Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it went away after a few minutes. Numbness in the arm: started that night and I would get numbness about every other day. Numbness lasts for about 10 hours and comes and goes throughout the day. About 6 weeks after the vaccine, i got numbness in the left leg. Now the numbness in the arm is pretty much gone but the leg numbness is there.
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| 47 | 2021-03-03 | vaginal haemorrhage |
pt reports having a heavier than normal vaginal bleeding/menstruation with the first dose on 1/19/21...
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pt reports having a heavier than normal vaginal bleeding/menstruation with the first dose on 1/19/21 which lasted 24 hrs Pt reports not menstruating when receiving her second dose on 2/8/21 but did experience heavy vaginal bleeding that lasted 24 hours.
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| 47 | 2021-03-04 | fibrin d dimer increased |
About 2 days after receiving the second dose I started experiencing redness and pain at the injectio...
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About 2 days after receiving the second dose I started experiencing redness and pain at the injection site. It was also warm to the touch. It was about almost 2 in in diameter. It got worse on the next day and it slowly started getting better, it went away in about 4 days. Then I had a gallbladder surgery that was scheduled on 01/29/2021. On 02/03/2021 I was feeling excruciating pain that I believe it was related to the gallbladder surgery. I went to the ER, the same hospital where I got the vaccine at and they ran a lot of tests on me, blood work, CT scans, ultrasounds and they told me my D Dimer was elevated: 2371. They attributed it to my recent surgery and told me to FU with my PCP. When I FU'd with my PCP Dr., she requested new blood work and this time my D Dimer was even higher than the results at the ED: 2610. That was on 03/01/2021. She is trying to get me in the Clinic she is concerned about cancer. I think it might be something regarding the vaccine.
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| 47 | 2021-03-04 | palpitations | heart racing, "just feeling wierd"- Evaluated by EMS-Cleared |
| 47 | 2021-03-05 | heart rate increased |
Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s...
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Heart rate increase approx. 4 minutes after injection. Tongue became swollen and itchy on the side s of the tongue about 18 minutes after injection, with a difficulty in ability to swallow. Extreme thirst for about 1.5 hours following the injection. No difficulty breathing, no throat swelling.
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| 47 | 2021-03-06 | palpitations |
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ...
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Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
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| 47 | 2021-03-07 | chest discomfort | chest tightness similar to her asthma attacks |
| 47 | 2021-03-10 | palpitations |
After the vaccine shot given around 3 PM , she was fine for the first 30 minutes of observation. 4 h...
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After the vaccine shot given around 3 PM , she was fine for the first 30 minutes of observation. 4 hrs later while at home she developed fever, chills for about 1 hr then followed by shortness of breath with palpitation. She also developed nausea with myalgia. She continued to have shortness of breath and palpitation throughout the night. . She tried to take deep breaths and tried to be active. She went to school the following day as a school teacher and she was monitored by her co-teachers . Finally at 10 am her symptoms according to he disappeared .
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| 47 | 2021-03-10 | chest pain |
Pt received vaccine and within 10 minutes experienced chest pain and nausea. Pt escorted via wheelch...
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Pt received vaccine and within 10 minutes experienced chest pain and nausea. Pt escorted via wheelchair to litter in separate space. Vitals taken at 1100: 120/38, HR 63 and 1114 114/81, HR 65. Pt symptoms resolved with rest.
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| 47 | 2021-03-11 | blood pressure increased, cardiac arrhythmia, heart rate increased, chest discomfort |
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ...
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Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
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| 47 | 2021-03-11 | chest discomfort |
Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at ...
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Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at 5 PM slept the rest of the day through 11 AM . Arm still swollen and red hot to the touch have put ice on it still getting bigger, tightness in chest and short of breath 2 days later , seen my dr she stated it is an allergic reaction and she recommended I do not get the second dose since this one has made me sick.
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| 47 | 2021-03-11 | hypotension, lightheadedness |
near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly...
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near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly >96%. Dipped to 88% a few times. no respiratory symptoms, rash, or throat swelling. transferred from clinic to ED via ambulance
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| 47 | 2021-03-13 | chest pain |
3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In a...
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3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In addition to listed symptoms numbness in feet develops and abdominal pain worsens; treatment with acetaminophen 11:30 PM. Fever of 100.8F; severe URQ/ULQ abdominal pain; moderate chest pain; treatment with oxycodone. Also joint pain in shoulders and wrists (clears after a few hours) 3/4/21: 1 AM. Chest pain and abdominal pain and numbness in feet persist, while dizziness and migraine develop; treatment with 2.5 mg Zolmitriptan 6 AM. Moderate abdominal pain. Treatment with oxycodone 7:30 AM extreme dizziness develops rendering me unable to walk or stand 8:30 AM: temperature 99.8F rest of day: abdominal pain persists
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| 47 | 2021-03-14 | cerebrovascular accident |
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh...
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PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
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| 47 | 2021-03-16 | fast heart rate |
47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covi...
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47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine. Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation. In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid. Patient has history of anxiety and jittery as well as nervousness after epinephrine. Patient was then given 1 mg p.o. Ativan for her symptom. On my evaluation, patient is not in respiratory distress, She is still Tachycardic in the 110s-120s Which is likely from the EpiPen. Patient stated that she normally stays tachycardic for a while after the epipen. Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling. Patient also has no wheezing on auscultation exam. We discussed the possibility of staying in the hospital under observation versus going home. Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.
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| 47 | 2021-03-16 | heart rate increased | Heart beating fast, Nauseous. Patient left at 3:47 pm, stating that she feels much better. |
| 47 | 2021-03-16 | chest discomfort | Persistent lightheadedness, chest pressure, and shortness of breath. Transported to ED. |
| 47 | 2021-03-16 | hypertension |
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower...
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Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
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| 47 | 2021-03-16 | ischemic chest pain, palpitations, heart rate increased, heart rate abnormal, chest pain, chest discomfort, blood pressure increased |
This is a follow up report starting from day after that first report was made -Report # 244159 - Sta...
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This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
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| 47 | 2021-03-17 | blood pressure decreased |
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal...
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Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
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| 47 | 2021-03-18 | chest discomfort |
Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadry...
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Felt faint at first , hives with in 10 mins, chewed 12.5 Benadryl, more hives chewed another Benadryl. Seemed ok after 45 post shot was allowed to leave drove home. Then about 1 hr post shot tight chest , itchy lips, puffy feeling lips, drive to urgent care, oxygen sat was 92 coughing swollen tongue gave myself epi, taken by ambulance to ER. Given more epi, Pepcid, steroids, Benadryl and Ativan. Was stable and discharged after 4 hrs. Next day very tired, throat sore lymph nodes swollen. Day 2 worse fever exhausted, sore muscles and joint pain. Increased Pepcid to 2 a day and 3 antihistamine a day. Day three increased steroids to 40 mg a day. Day 2 of increased steroids. Lymph nodes down , still exhausted, nausea, sore.
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| 47 | 2021-03-18 | deep vein blood clot |
Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ...
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Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
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| 47 | 2021-03-19 | chest pain | Chest pain, funny feeling in throat, hoarse voice, headache, flushed |
| 47 | 2021-03-20 | loss of consciousness, fainting |
Headache, dizziness followed by blackout/fainting resulting in head bruise and swelling. Rest at hom...
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Headache, dizziness followed by blackout/fainting resulting in head bruise and swelling. Rest at home, cold compress for swelling, Tylenol.
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| 47 | 2021-03-21 | palpitations |
received vaccine 3/19/21 at 23:30 pm. Woke up at 4:20 am 3/20/21 with extreme pain and burning sen...
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received vaccine 3/19/21 at 23:30 pm. Woke up at 4:20 am 3/20/21 with extreme pain and burning sensation at injection site. swelling noticed at injection site 2 hours later. iced area. Congestion and coughing began around this time. Fatigue began around 5 pm. Kept falling asleep. Arm still swollen and burning. Iced again. Went to bed at 8:30 pm. Woke up at 10:30pm with diarrhea and heart racing. Heart raced for 30 minutes. Went back to bed and slept for 10 hours. Woke up at 9 am with grogginess and some cough and congestion.
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| 47 | 2021-03-23 | heart rate increased |
Six hours after the shot at 6 PM in the evening, I went from a resting heart rate of 65 when it jump...
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Six hours after the shot at 6 PM in the evening, I went from a resting heart rate of 65 when it jumped to 100, then 105 and 108. I have not suffered a tachycardia event for over two years. I worked hard through diet and exercise to change my heart palpitations. But this event lasted for about 30 minutes give or take and we treated at home via breathing meditation exercises. During and afterwards, I experienced Sharp pain and burning underneath the breast bone by the heart. Gerd-type symptoms in the lower esophagus also plagued me. At 1 AM I was awoken to an extreme nausea sensation. As of the next day, my heart feels better but my stomach feels off. I am able to hold foods down.
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| 47 | 2021-03-23 | fibrin d dimer increased, chest pain |
at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At ...
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at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine. At 30 min past the vaccine the vaccine center gave me 25 mg of benadryl and had me follow up with an urgent care center. I went home and took hydrozine because I continued to have hives and a rash, I could not afford to seek emergency help at the urgent care center and stated that to the vaccine center. The vaccine center said because I was able to breathe they could not transport me to the emergency room or urgent care center.
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| 47 | 2021-03-24 | chest discomfort |
Patient received her first Pfizer vaccine at hospital on 3/15/21. Given her history of anaphylaxis w...
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Patient received her first Pfizer vaccine at hospital on 3/15/21. Given her history of anaphylaxis with demerol she was asked to stay for 40 minutes. She is unsure how soon her reaction started but thinks within 20 minutes of getting a shot. Her symptoms started with a sore throat, followed by throat tightness, chest tightness. These symptoms improved a bit with drinking water but didn't go away. She didn't experience tongue swelling or lip tingling like she does with eating certain foods (see below). She took her own benadryl and was better in 15-20 minutes and denies recurrence of symptoms. Denies dizziness/fatigue, urticaria, conjunctivitis, nasal congestion, wheezing, n/v/d post immunization.
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| 47 | 2021-03-24 | fainting |
overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcuta...
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overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), second dose, intramuscular, administered in left arm on 19Feb2021 17:00 as single dose for covid-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder), obesity, allergic rhinitis, penicillin allergy (rxn in childhood - suspect not actually allergic). Concomitant medications included Fluoxetine, Bupropion, Adderall, Cetirizine and Ibuprofen. On 19Jan2021 11:00 patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) Lot number=EL9264, intramuscular on left arm. In the hours following the second injection patient developed a cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm, size approx 12mm x 5mm, minimal depth below skin surface. Itching waxed and waned in intensity, was worst early on, but still had some occasional itching two days later at which point lesion was sort of like a pin-point sized scab in appearance. Induration gradually resolved but was still detectable the day after the injection. Currently (4 days after injection) overlying skin with faint hyperpigmentation and feels like sandpaper on palpation, no warmth, induration, or erythema. (Healing, non-concerning, is sort of like a not-quite-a-scab, 8mm x 1mm - though I did not note any abrasions or watery exudate while it was symptomatic. On an unspecified date the events outcome was recovered. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-03-25 | fast heart rate |
15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was take...
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15 minutes after receiving her vaccination, she developed lightheaded and photophobia. She was taken to a private section of the arena for monitoring. She had mild tachycardia with heart rate of 105 bpm. With subsequent monitoring, her HR normalized. After 20 minutes of monitoring, her symptoms fully resolved.
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| 47 | 2021-03-25 | heart rate increased |
20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swell...
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20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swelling in my throat and increased heart rate. I took 10 mg of liquid cetirizine hcl oral solution which I carry with me. I waited an additional 25 minutes at the facility and the itching and swelling and heart rate diminished. I took 800 mg ibuprofen and 1000 mg Tylenol to treat the severe headache. About 30 minutes after that, my headache was much better. I went home and slept for 3 hours and felt almost normal thereafter.
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| 47 | 2021-03-25 | palpitations | sob, heart racing. Evaluated by EMS-Cleared |
| 47 | 2021-03-26 | palpitations |
After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in t...
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After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in the fingers. Paramedic came and took vitals signs and ekg. Patient symptoms subsided and she spoke to a behavioral health. As her smptoms dessipate she was release by the nurse.
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| 47 | 2021-03-26 | chest pain | Left pain burning in breast. |
| 47 | 2021-03-26 | heart rate increased, hypertension |
patient was complaining of reaction s/p 1st dose covid vaccine approximately 15-20minutes after vacc...
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patient was complaining of reaction s/p 1st dose covid vaccine approximately 15-20minutes after vaccine administration. Patient was alert and oriented and states that she is "itchy all over" including her throat. Her SBP at the time is 180s and elevated HR in the low 100s. O2 sat remained >98%. She denies any reactions to previous vaccinations but had an anaphylactic reaction to walnuts before. Patient examined with no visible rashes, patent airway, no enlargement or swelling of tongue or lips. Verbal order from Dr to start IV access and was given Benadryl 25 mg and Dexamethasone 4mg IV. Patient tolerated well. Vital signs rechecked every 2 mins with SBP trending down and HR stabilizing in the 90s. Patient denies any chest pain, SOB, cough, but complains of mild nausea. Patient was kept in clinic for observation for 2 hours and was discharged in stable condition. Spouse came to drive patient home as she was somnolent from benadryl 25mg IV administration. Spoke with patient again today 3/27 to check on her. She states there is still some pruritis at R deltoid injection site with some swelling. She notes it is about 50% improved in itchiness and swelling since the evening of vaccination. Patient reports that she did not have any swelling of tongue, lips, or throat during observation post vaccination and since being released from clinic observation.
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| 47 | 2021-03-29 | chest discomfort |
Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a co...
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Pressure on chest; Respiratory allergies; swollen right hand; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 25Feb2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies and food sensitivities. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR) and lansoprazole (PREVACID); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 via nasal swab COVID-19 on 08Jul2020 with negative result and on 07Jan2021 with unknown results. The patient experienced pressure on chest, respiratory allergies and swollen right hand on 26Feb2021 at 10:30 PM. The patient was treated with diphenhydramine hcl (BENEDRYL) for the events, pressure on chest, respiratory allergies and swollen right hand. The outcome of events, pressure on chest, respiratory allergies and swollen right hand was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
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| 47 | 2021-03-30 | chest pain |
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria...
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it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
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| 47 | 2021-04-09 | blood pressure increased, heart rate increased |
Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; Thi...
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Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient don't have heart problems or blood pressure problems. The patient's concomitant medications were not reported. The patient experienced heart rate exceeded 100 beats a minute five minutes after the injection and blood pressure went up on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 1 day due to the events. Therapeutic measures were taken as a result of the events which included Heart monitor/ IV for flushing. The patient did not recover from the events. Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Blood pressure went up" and "Heart Rate exceeded 100 beats a minute five minutes after the injection" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-04-13 | blood glucose increased |
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa...
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hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
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| 47 | 2021-04-14 | hypotension |
N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) R42 - Dizziness R4...
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N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) R42 - Dizziness R42 - Lightheadedness I95.9 - Hypotension Z45.02 - AICD discharge
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| 47 | 2021-04-14 | platelet count decreased |
Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms s...
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Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms started one week prior
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| 47 | 2021-04-15 | blood clot |
Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/...
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Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/2021 my right leg began to swell terribly and then on 4/6/2021 it was discovered that I had one big and many small blood clots in my right leg.
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| 47 | 2021-04-17 | transient ischaemic attack |
while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken...
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while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray); numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain; had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;
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| 47 | 2021-04-18 | blood clot, deep vein blood clot, pulmonary embolism |
Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a co...
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Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ENG207), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (at the age of 47years) as single dose for Covid-19 immunization. The patient received the dose 1 of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:30 (Batch/Lot Number: ENG203) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included essential tremor, insulin resistance, and anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, metformin, bupropion, and citalopram; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots, pulmonary embolisms, and a DVT (deep vein thrombosis) on 04Apr2021 (11:00AM). The patient was hospitalized due to the events for 4 days. The patient was treated with Heparin and Eliquis. The patient was tested for Covid-19 post vaccination via Nasal Swab on 03Apr2021 with Negative result. The outcome of events was recovering. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).
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| 47 | 2021-04-20 | fainting, loss of consciousness |
positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago whil...
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positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago while going to bathroom; felt dizzy and fainted/light-headed; abnormal EKG; got head injury; Had a weird rash on elbows; headaches; concussion; sore throat; Started feeling more unwell several days ago; been fatigued for weeks; coughing with phlegm; mouth sores; laryngitis; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration, administered in right arm on 14Jan2021 at 08:30 at a single dose, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration, administered in right arm on 03Feb2021 at a single dose for COVID-19 immunisation at hospital. Medical history included known_allergies Penicillin, sulfur, NSAIDs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination. Concomitant medications included gabapentin, trazodone, fluoxetine hydrochloride (PROZAC), oxymetazoline hydrochloride (CLARITIN ALLERGIC). Since the vaccination, patient has been tested for COVID-19. After second dose, but before patient left waiting area, on 17Mar2021, felt dizzy & fainted. Taken to ER. Had an abnormal EKG. Followed up with heart doctor. Blacked out several weeks ago while going to bathroom & got head injury. Husband and 2 sons tested positive for COVID mid March. Had a weird rash on elbows, been having headaches. Went to doctor about rash; not sure of cause. Told representative several times during contact updates for sons; representative said patient can't get COVID if she has been vaccinated. Went to doctor about head injury (diagnosed concussion on 17Mar2021. Supposed to see cardiologist and orthopedist for follow up but need to postpone due to positive COVID test on 17Mar2021. Started feeling more unwell several days ago; been fatigued for weeks. Symptoms included coughing with phlegm, headache, light-headed, mouth sores, sore throat, laryngitis, extreme fatigue, muscle aches. Positive rapid test 05Apr2021; PCR test on 05Apr2021; waiting for results. Treatment received for the adverse events. The outcome of the event positive COVID test was unknown and patient was recovering from all other events.
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| 47 | 2021-04-24 | hypotension, blood pressure increased, ischemic chest pain, palpitations |
kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; col...
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kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.
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| 47 | 2021-04-27 | chest pain |
chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness ...
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chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness of breath; This is a spontaneous report from a contactable consumer(patient). A 47-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) on 21Jan2021 at 04:00 PM via an unspecified route of administration in left arm at single dose for covid-19 immunization. Patient was 47 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Patient did not receive any other medications in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination. On 21Jan2021 at 8PM patient had shortness of breath, chest pain, heart burn, chills, fever, body pains, terrible headache, tired, and weak. It lasted until 10AM the next day. Effects lasted for 12 hours. On 06Jan2021 patient tested for covid post vaccination with test name Saliva and result received was negative. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 47 | 2021-04-28 | fainting |
faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable ...
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faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events. Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
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| 47 | 2021-05-03 | loss of consciousness |
After receiving her vaccine, client states she felt dizzy and confused, then lost consciousness. Vi...
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After receiving her vaccine, client states she felt dizzy and confused, then lost consciousness. Vital signs BP 136/84, O2Sat 99%, HR 100. Client was alert and awake. Client advised to be transported to the ER. Client refused. Client went home.
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| 47 | 2021-05-04 | palpitations |
Heavy Dizzy spells/vertigo lasting about 3 hours, starting 3 days after shot, accompanied by ?jelly ...
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Heavy Dizzy spells/vertigo lasting about 3 hours, starting 3 days after shot, accompanied by ?jelly legs? and heart palpitations. On and off for 2 weeks. Visited ER on 5/1 thinking of possible heart attack, all test came back normal. Sent home with not diagnostic ?might be side effects from vaccine?. Still feeling sick not taking second shot
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| 47 | 2021-05-04 | fainting |
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo...
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fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 47 | 2021-05-13 | palpitations |
Facial spasms left side of forehead starting 72 hours; Heart palpitations around 80 hours after seco...
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Facial spasms left side of forehead starting 72 hours; Heart palpitations around 80 hours after second dose; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 17Apr2021 at 15:00 (at the age of 47-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received sulfa; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 at 03:15 PM (at the age of 46-year-old) at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations around 80 hours after second dose on 20Apr2021. Lasted only 20 minutes. Facial spasms left side of forehead starting 72 hours after second dose on 20Apr2021 at 15:00 and lasted 5 days. Since the vaccination, patient had not been tested for COVID-19. The outcome of the event facial spasms was recovered in Apr2021 for 5 days, outcome of event palpitation was recovered on 20Apr2021 for 20 minutes. No follow-up attempts are possible. No further information is expected.
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| 48 | 2020-12-31 | loss of consciousness, fainting |
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced s...
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Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
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| 48 | 2021-01-03 | heart flutter |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | chest pain, heart rate increased |
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula...
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Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
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| 48 | 2021-01-03 | heart rate irregular, fast heart rate, palpitations |
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw...
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dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | hypertension |
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush...
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employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
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| 48 | 2021-01-04 | chest discomfort |
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa...
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15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
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| 48 | 2021-01-04 | fast heart rate |
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em...
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Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
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| 48 | 2021-01-04 | blood pressure increased |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-04 | heart rate irregular, palpitations |
Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart p...
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Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on the left arm on 23Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dust mites, sinusitis, depression. The patient was not pregnant. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), and lamotrigine (LAMICTAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 24Dec2020 23:00, the patient experienced heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat. There is no history of any cardiovascular diseases or abnormal findings. No caffeine or alcohol intake on the day of the occurrence. No treatment was received for the adverse events. Outcome of the irregular heart beat was not recovered while of the remaining event was recovered on 25Dec2020 23:00. The events were considered non-serious.
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| 48 | 2021-01-04 | palpitations, chest discomfort |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | chest discomfort |
chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, a...
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chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago). There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed. The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better. For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020. The clinical outcome of the events was recovered on an unspecified date.
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| 48 | 2021-01-05 | chest discomfort |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | chest discomfort |
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit...
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chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
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| 48 | 2021-01-06 | fast heart rate |
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minu...
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Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
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| 48 | 2021-01-06 | hypertension |
NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having...
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NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.
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| 48 | 2021-01-06 | chest pain |
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking...
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Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
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| 48 | 2021-01-06 | hypertension |
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl...
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left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
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| 48 | 2021-01-07 | ischemic chest pain, increased heart rate |
Angina & Tachycardia Narrative: Employee transferred to the ER for further treatment. Employee given...
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Angina & Tachycardia Narrative: Employee transferred to the ER for further treatment. Employee given DIPHENHYDRAMINE INJ,SOLN 25MG/0.5ML IV Now dose and METHYLPREDNISOLONE INJ,SOLN 125MG/1VIAL IVP ONCE. 12 leads EKG showed Sinus Tachycardia. No other respiratory distress reported. The employee was closely monitor in ER for couple of hours. Employee reported feeling better after pharmacological interventions. Employee's health status improved. ED Provider sent patient home in stable condition with 5-6 Steroids PO treatment.
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| 48 | 2021-01-07 | heart rate increased |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | fast heart rate, chest discomfort |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-07 | palpitations |
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b...
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Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
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| 48 | 2021-01-07 | blood pressure decreased |
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going...
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about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
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| 48 | 2021-01-07 | heart rate increased, hypertension, increased heart rate |
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair t...
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diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
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| 48 | 2021-01-07 | chest discomfort | headache, muscle aches, chest tightness, lethargic, lightheaded for three days. |
| 48 | 2021-01-07 | fast heart rate | tachycardia in 90s, 100s, and 110s x about 4 hours |
| 48 | 2021-01-08 | blood pressure increased, heart rate increased |
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest an...
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Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
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| 48 | 2021-01-08 | heart rate increased, blood pressure increased | Elevated Heart rate and blood pressure. Blotching to chest and neck. difficulty swallowing. |
| 48 | 2021-01-08 | palpitations |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-08 | chest discomfort |
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ...
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Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
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| 48 | 2021-01-08 | heart rate increased, chest discomfort |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-09 | chest discomfort |
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l...
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1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
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| 48 | 2021-01-09 | fast heart rate |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-10 | loss of consciousness |
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an...
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After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
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| 48 | 2021-01-10 | fast heart rate |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | chest discomfort |
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine...
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Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
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| 48 | 2021-01-11 | pallor |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | pulse abnormal |
January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck sw...
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January 4. Noticed neck swelling and pulsating neck while brushing teeth. No fever noted. Neck swelling noted with bounding pulse in jugular region x 9 days. Seen by physician Jan 5. Neck ultrasound performed Jan 11. Awaiting results.
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| 48 | 2021-01-11 | chest pain |
Pt was given 2nd dose, monitored x 15 min with no complaint of symptoms of rxn. Left clinic, and sho...
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Pt was given 2nd dose, monitored x 15 min with no complaint of symptoms of rxn. Left clinic, and shortly after began having left-sided chest pain requiring ED visit approximately 5 hours after dose. Per ED notes, pt has hx HTN. Initial BP in ED 142/97. Dx is ED was CP r/o ACS. Pt was advised by ED MD to be admitted, however pt refused admission with a plan to f/u with her own cardiologist. Pt ultimately left AMA from the ED.
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| 48 | 2021-01-12 | chest discomfort |
Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start...
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Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 48 | 2021-01-12 | chest discomfort, palpitations |
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vo...
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Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
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| 48 | 2021-01-12 | chest pain |
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to fe...
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Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
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| 48 | 2021-01-12 | blood pressure increased |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS. -Severe.
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| 48 | 2021-01-12 | blood pressure increased |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS.-Severe
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| 48 | 2021-01-12 | fainting | Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild |
| 48 | 2021-01-13 | blood pressure increased |
After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, g...
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After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
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| 48 | 2021-01-13 | haemoglobin decreased |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | hypertension |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | hypertension |
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at...
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Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
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| 48 | 2021-01-13 | hypertension |
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu...
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Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
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| 48 | 2021-01-13 | heart rate increased | Reported heart rate of 108, a week of paresthesias. Symptoms resolved |
| 48 | 2021-01-13 | chest discomfort |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-14 | skin turning blue |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | fast heart rate |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-16 | heart rate increased | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-16 | fast heart rate |
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t...
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Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
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| 48 | 2021-01-17 | fast heart rate, palpitations, heart rate increased, oxygen saturation decreased |
Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she s...
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Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause. Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal). She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
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| 48 | 2021-01-17 | chest pain |
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ...
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The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
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| 48 | 2021-01-18 | hypotension |
vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressur...
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vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 05Jan2021 10:00 to 05Jan2021 10:00 at a single dose for COVID-19. Medical history included asthma, sibo, allergies to wheat, gluten, corn, tomato and peanuts. The patient's concomitant medications were not reported. It was reported that the patient's initial response to shot was severe nausea and dizziness, low blood pressure lasted 24hrs on 09Jan2021. 5 days later, the patient had nausea, vomiting, chills after meal, severe headache and stomach pain 72 hrs. The patient received IV fluids as treatment for all events. The patient underwent lab tests and procedures which included Covid Nasal Swab Test on 04Jan2021 which tested negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 48 | 2021-01-19 | hypertension |
just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report fr...
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just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "having some high blood pressure", she "feels like throwing up" and "she doesn't feel well". The patient outcome of the events was unknown. The information on the batch number has been requested.
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| 48 | 2021-01-20 | fainting, fainting |
Employee received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at...
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Employee received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at the kitchen sink making breakfast at 10:00 am on 1/13/21 she fainted and woke up on the floor. Her child stated that she had fallen to the floor. She did not hit her head. This employee had an appointment to see her PCP the following day concerning something else. She did relay this information to her PCP who is asking that she follow up with a cardiologist. The PCP had no opinion if the vaccine may have caused her syncope. She currently has a appointment with a cardiologist.
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| 48 | 2021-01-20 | fast heart rate |
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain...
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Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow up attempts are possible. No further information is expected.
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| 48 | 2021-01-20 | chest discomfort |
Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heavin...
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Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heaviness without SOB or difficulty swallowing. Itching began starting with face then neck, chest and torso. Itching then spread to the whole body with a patina rash appearing on the face, neck and chest a few hours later. Immediately took dose of liquid Benedryl upon arriving home. Followed up by dose of Zyrtec. Continued monitoring sxs throughout the evening. Took additional 2 doses of Benedryl with a dose of Singular. Sxs severity lessoned though the night and into the next day. Mild itching and a few patches of the rash remained the next day 1/20/21. Continued taking antihistamine and allergy medication. All sxs have resolved as of 1/21/21
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| 48 | 2021-01-20 | chest discomfort |
Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a ...
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Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
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| 48 | 2021-01-20 | fainting, fainting |
Patient received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at ...
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Patient received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at the kitchen sink making breakfast at 10:00 am on 1/13/21 she fainted and woke up on the floor. Her child stated that she had fallen to the floor. She did not hit her head. Patient had an appointment to see her PCP the following day concerning something else. She did relay this information to her PCP who is asking that she follow up with a cardiologist. The PCP had no opinion if the vaccine may have caused her syncope. She currently has a appointment with a cardiologist.
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| 48 | 2021-01-20 | chest pain, palpitations | palpitations, cp. no rash, no facial swelling. |
| 48 | 2021-01-21 | blood pressure decreased | Extreme nausea, dizziness, decrease in blood pressure |
| 48 | 2021-01-21 | palpitations, chest discomfort |
Patient received her 1st COVID immunization and shortly after developed chest tightness/pressure, p...
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Patient received her 1st COVID immunization and shortly after developed chest tightness/pressure, palpitations, and lightheadedness. She reported a previous history of anaphylactic reaction to shell fish and IV dye.
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| 48 | 2021-01-21 | fast heart rate |
Started with a terrible headache the morning after vaccine. By the afternoon along with the headach...
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Started with a terrible headache the morning after vaccine. By the afternoon along with the headache, I had muscle aches. By 1am, I was having a low grade fever, chills, and tachycardia (120-130bpm).
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| 48 | 2021-01-22 | heart rate increased | Fever100.5, body aches, chills, shaking, headache, rapid heart rate |
| 48 | 2021-01-23 | chest discomfort |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | blood pressure increased |
Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able t...
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Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able to return to full duty.
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| 48 | 2021-01-24 | pallor |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-24 | chest discomfort |
approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest dis...
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approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest discomfort. No respiratory symptoms, REsolved after 30 minutes and discharged to home.
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| 48 | 2021-01-25 | hypotension, hypertension |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | blood pressure increased, heart rate increased |
Patient felt dizzy 15 minutes after receiving the Pfizer vaccine on 1/26. Her BP and pulse continued...
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Patient felt dizzy 15 minutes after receiving the Pfizer vaccine on 1/26. Her BP and pulse continued to elevated and she stated that she was short of breath. I contacted our rapid response team and she was transported to the ED for evaluation.
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| 48 | 2021-01-25 | heart rate increased, blood pressure increased |
Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were eleva...
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Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were elevated and she stated to feel short of breath. Rapid response team responded and the patient was taken to the ED for evaluation.
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| 48 | 2021-01-25 | chest discomfort |
Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid ...
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Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid vaccine. Slight substernal chest tightness w/ feeling like there is a lump in her throat. No sob/tongue swelling/nausea/vomiting or rash reported. Was given benadryl w/ mild relief.
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| 48 | 2021-01-25 | lightheadedness |
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ...
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Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
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| 48 | 2021-01-25 | blood pressure increased |
Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes...
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Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
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| 48 | 2021-01-25 | lightheadedness, fast heart rate |
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night...
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Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
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| 48 | 2021-01-25 | chest pain |
Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and...
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Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and saw a provider via telehealth. She gave me Augmentin and prednisone. My sinuses were irritated. I had flu like symptoms but no fever. I was treated for strep throat. I have had mild throat burning since and have not fully recovered. I have had a severe headache ever since and have had to rotate Tylenol and ibuprofen everyday. I went into the ER 01/22/2021 with severe chest pain and they said I had GERD.
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| 48 | 2021-01-25 | palpitations, pulse abnormal |
neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding puls...
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neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding pulse (palpitations); This is a spontaneous report from a contactable consumer on behalf of herself. A 48-year-old female patient received her first BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EH9899, via an unspecified route of administration on 28Dec2020 at SINGLE DOSE at left upper arm for COVID-19 immunisation. There were no relevant medical histories or concomitant medications. The patient had a vaccination on 28Dec2020 and seven days later on 04Jan2021 her neck was mildly swollen and that same day it became more swollen and she had a bounding pulse also reported that had mild superficial neck swelling and a bounding pulse in her neck. The swelling has gone down, but got worse in the evening. The bounding pulse (palpitations) in her neck has improved but got worst at night, still occurred at night. No difficulty breathing and/or swallowing. She went to her physician on 05Jan2021 to find out why occurring. She was called to see if based off this symptom if she should have her second shot of vaccination. Followed up with her MD and had an Ultrasound (US) of her jugular in Jan2021 and all was normal. The outcome of the events was resolving.
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| 48 | 2021-01-26 | chest discomfort |
About 15 minutes after receiving the vaccine, patient reported some tightness in her chest. A few mi...
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About 15 minutes after receiving the vaccine, patient reported some tightness in her chest. A few minutes later, she had a dry cough. The facility doctor checked her out and said her vitals were good and her breathing sounded normal. She continued with the work day as normal.
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| 48 | 2021-01-26 | chest discomfort |
Chest tightness that started about 10 days after first dose. Lasted 4 days. Same symptoms started t...
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Chest tightness that started about 10 days after first dose. Lasted 4 days. Same symptoms started two days after the second dose. I have no cardiac history. Husband ( healthy marathon runner) also experienced chest tightness after the first dose but not his second dose. My father, who is 80 is also experiencing chest tightness after his first dose. He is scheduled for a stress test because he does have a cardiac history. I am a physician.
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| 48 | 2021-01-26 | heart attack, chest pain |
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest...
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Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
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| 48 | 2021-01-26 | chest discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA Vertigo, low grade fever, fatigue started in afternoon 26 Jan ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Vertigo, low grade fever, fatigue started in afternoon 26 Jan 2021 Vertigo all day, slight tightness in chest 27 Jan 21
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| 48 | 2021-01-26 | heart rate increased | rash knot soreness fatigue headache itching fast heartrate body aches |
| 48 | 2021-01-27 | chest discomfort | Itching, vomiting, feeling flush, chest tightness |
| 48 | 2021-01-27 | chest pain |
Left sided parietal, left temple down to auditory area, and left lower occipital region with pulsati...
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Left sided parietal, left temple down to auditory area, and left lower occipital region with pulsating and intense throbbing . The symptoms aggravates by bending and sudden movement . This had been worsening. The Pfizer first dose HA was brief at the same site. After the second dose of pfizer covid vaccine the above symptoms continues and intolerable. left sided piercing chest pain(CP) front through the back. This is different from CP I had. I was going to the hospital -i took my Imdur, ASA and benadryl - these relieved the symptoms
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| 48 | 2021-01-27 | hypertension |
Received vaccine at 3:10. At 3:20 reported feeling a little dizzy. Checked VS BP176/102 HR 84 Pulse...
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Received vaccine at 3:10. At 3:20 reported feeling a little dizzy. Checked VS BP176/102 HR 84 Pulse Ox98% Temp 98.2. Patient reports she has high blood pressure and her PMD has told her to take a second dose of her BP medication if her pressure is elevated. Patient felt well enough to walk back to unit (escorted by RN) to take her medication, at 3:30PM. Re-checked BP at 3:50 178/106, pulse 85 Re-checked BP at 4:10 165/95, pulse 82 After consulting with NP and patient 50 mg oral Benadryl given at 4:15. Patient would not wait in vaccine unit after this and insisted on returning to her unit, instructed her to return or go to ER if symptoms worsen or do not improve. She still felt a little "off" and slightly dizzy but dizziness was not worse when walking and she reports that she did not feel faint.
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| 48 | 2021-01-27 | chest pain, fast heart rate, palpitations, blood glucose increased |
Shortly after receipt of the first dose of the Pfizer-BioNTech Covid-19 vaccine, this patient began ...
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Shortly after receipt of the first dose of the Pfizer-BioNTech Covid-19 vaccine, this patient began complaining of palpitations, "warmth" radiating from the center of chest, and anxiety while in the observation area. She was moved to a quieter portion of the vaccine area where she was asked to lay supine on a bed. She did not have any difficulty breathing or swallowing and also did not have any visible rashes or hives. Her vital signs were as follows: 3:00 PM- BP: 148/85 mm Hg, HR: 144 beats/minute, SpO2: 100% 3:05 PM- BP: 148/85 mm Hg, HR: 156 beats/minute, SpO2: 100% 3:11 PM- BP: 120/76 mm Hg, HR: 127 beats/minute, SpO2: 100% 3:17 PM- BP: 120/76 mm Hg, HR: 120 beats/minute, SpO2: 100% 3:22 PM- BP: 130/77 mm Hg, HR: 132 beats/minute, SpO2: 100% Emergency medical services was called. She stated she felt better around 3:17 pm onwards, however, it was suggested that she visit the Emergency Department due to her ongoing tachycardia. She was subsequently transferred to the Emergency Department for observation and work up. She is awaiting work up currently in the Emergency Department, without any complaints asides from anxiety.
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| 48 | 2021-01-28 | palpitations, heart rate increased | Rapid heart rate, heart palpitations, stomach pain?started 12 hours after vaccine. |
| 48 | 2021-01-29 | heart rate increased, chest pain |
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and...
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Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
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| 48 | 2021-01-29 | chest discomfort, hypertension |
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood press...
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with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's, fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection. With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided. nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight. still have headache.
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| 48 | 2021-01-30 | fainting |
Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles inter...
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Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles interrupted by nightmares, also fever (101), chills and muscle/ joint aches 12/29: nausea/ vomitting with worsening joint/muscle aches. Sent home without finishing workday. Fever continue all day and all night with syncopal episode on friday night. My husband gave me ice bath to break the fever which was 102 ( according to him). *unable to got to the bathroom unassisted from Friday afternoon and all day Saturday* 12/30: fever, muscles, joiny aches and headaches persisted but lesser in severity 12/31: first day fever free ( last and only dose of tylenol at 6am). Mild headache at time of filling up this report(8:51pm) Able to go the bathroom unassisted all day.
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| 48 | 2021-01-30 | heart rate increased, chest pain, palpitations |
Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and sta...
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Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and started to swell. It was a similar feeling to getting contrast through an IV. I took two Benadryl and Ibuprofen to help relieve the symptoms. The metal taste lasted until the next day. Friday- The next morning I woke if with a fever 100° . Minus the mild arm pain, I initially felt ok but as the day went on I felt worse, like the flu. By 11am my heart was racing even at rest. My pulse is usually in the low 60 range (athlete) and it was 95-115 from 11am until late that evening. Saturday- symptoms gone but huge dark circles under my eyes. I felt great though.
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| 48 | 2021-01-31 | palpitations, chest discomfort |
Chest pressure, heart racing, and feeling of breathlessness. Occurred after first one and passed ...
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Chest pressure, heart racing, and feeling of breathlessness. Occurred after first one and passed it off as anxiety but when it happened this time I was concerned it was side effect as not having any added stress or anxiety.
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| 48 | 2021-01-31 | chest discomfort |
Within 5 mins of vaccine I felt my chest tightening. I could still breathe but I could tell my lung...
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Within 5 mins of vaccine I felt my chest tightening. I could still breathe but I could tell my lungs were tight. Taking a deep breath was not normal. Soon after I felt the muscles between my shoulder blades starting to tighten as well. I think a response to my tightness in my chest. We were instructed to stay in facility for 15 mins. My symptoms did not increase after 15 mins so I went home. That was 5:00pm. By bedtime at 10:00pm my symptoms had resolved. I?m not sure if I should get my second dose?
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| 48 | 2021-02-01 | anaemia |
SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT L...
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SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT LIKE THEY WERE GOING TO POP AND SOME SOB
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| 48 | 2021-02-02 | chest discomfort |
Patient became short of breath, had chest pain, and nausea about 20 minutes after her second COVID v...
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Patient became short of breath, had chest pain, and nausea about 20 minutes after her second COVID vaccine
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| 48 | 2021-02-03 | palpitations | Increasing palpitations over the past two days along with some diarrhea and nausea |
| 48 | 2021-02-03 | palpitations |
Patient states she was waiting in post vaccination area when she began to become very anxious. Her h...
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Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
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| 48 | 2021-02-03 | lightheadedness, chest discomfort |
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di...
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Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
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| 48 | 2021-02-05 | palpitations | Felt racy heart, lightheadedness |
| 48 | 2021-02-08 | chest pain |
Had non intractable headache for several weeks before and after second vaccine on 1/29/21. Went to E...
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Had non intractable headache for several weeks before and after second vaccine on 1/29/21. Went to ER for chest pain and headache on 2/8/21. Admitted to Hospital.
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| 48 | 2021-02-08 | hypertension, heart rate increased |
Rapid heart rate over 143, high blood pressure 247/100 and something, hard to catch my breath and fe...
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Rapid heart rate over 143, high blood pressure 247/100 and something, hard to catch my breath and felt weird. Onset within 5 minutes. Lasted greater than 30 minutes.
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| 48 | 2021-02-10 | chest pain | High fever 102.9-103.4, Headache, chills, body aches, chest pain. |
| 48 | 2021-02-11 | hypertension, heart rate increased |
I woke up and mid morning I had body aches and a headache. After lunch, I was lightheaded and dizzy....
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I woke up and mid morning I had body aches and a headache. After lunch, I was lightheaded and dizzy. BP was high and heart rate was high.
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| 48 | 2021-02-15 | chest discomfort |
1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - ...
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1. Shortness of breath - tightness in chest; moderate x 1 day; intermittent; 2. Headache moderate - severe x 2 days 3. Muscle/joint pain entire body and injection site - moderate x 2 days; mild continuous; 4. Fever, chills x 1.5 day 5. Fatigue - mild ongoing; 6. Swollen lymph node in neck on the left side (same side received injection).
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| 48 | 2021-02-15 | chest discomfort | Sore throat fever body aches chest tightness headache |
| 48 | 2021-02-15 | chest pain |
Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, bo...
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Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, both shoulders, chest pain when taking a deep breath and headache began approximately 15 hours after injection and continue at 3pm on Tuesday the 16th of February. Just not the "happy camper, I usually am. :(
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| 48 | 2021-02-16 | cerebral haemorrhage |
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ...
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Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
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| 48 | 2021-02-17 | loss of consciousness |
pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contac...
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pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-18 | heart rate increased, chest discomfort |
within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, ...
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within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, complaining of rapid heart rate, not feeling well, lightheaded, chest pressure, tingling. No LOC. Called 911 , Epi auto injection given 0.3 mg; reported improvement in chest pressure and breathing shortly afterwards, taken to local hospital via EMS in stable condition. Total time in clinic: approximately 40 minutes from vaccination to EMS leaving.
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| 48 | 2021-02-21 | fainting |
Patient admitted after syncopal episode, found subsequently to have a splenic artery aneurysm for wh...
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Patient admitted after syncopal episode, found subsequently to have a splenic artery aneurysm for which surgery not recommended. Pt was discharged on small-dose anxiolytic
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| 48 | 2021-02-21 | fainting |
patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second d...
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patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.
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| 48 | 2021-02-22 | palpitations |
I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fe...
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I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fell out in clumps. I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021. From my stay in the hospital on 07/14/2020 up until 02/15/2021 I had the minimum hair loss that one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps. I also started experiencing heart palpitations along with SOB in the evenings after the first vaccine. Upon the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.
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| 48 | 2021-02-23 | heart rate increased |
-Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk f...
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-Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk front and back beginning at approx. hour 42, itchy and red -elevated HR noticed at hour 48 (100BPM)
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| 48 | 2021-02-23 | chest pain |
Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Che...
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Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Chest pain; Cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (Lot # EL1283) intramuscular at single dose in the right arm on 15Jan2021 and the second dose at single dose in the left arm on 03Feb2021 11:30, for covid-19 immunisation. Medical history included exposure to sars-cov-2 in Dec2020 (Her mother ended up positive for Covid and she was exposed to her and showed symptoms). There were no concomitant medications. On 03Feb2021, the patient experienced felt like she had Covid plus the flu with outcome of recovered on 05Feb2021, very congested chest with outcome of recovered on 06Feb2021, flu like symptoms with outcome of recovered on 05Feb2021, chest pain with outcome of recovered on 05Feb2021, cough with outcome of recovered on 06Feb2021, shortness of breath with outcome of recovered on 06Feb2021. The patient underwent lab tests and procedures which included oxygen saturation: normal on an unspecified date, sars-cov-2 antibody test: positive on an unspecified date. Therapeutic measures were taken as a result of felt like she had covid plus the flu, flu like symptoms. The events were described as follows: Patient said that she had some weird side effects from the 2nd vaccine, but not the first dose and believes that she had Covid in Dec2020. Patient said that she had flu like symptoms, she said it felt like she had Covid plus the flu. She said that she also had chest pain, a very congested chest, a cough, and shortness of breath. She did not have that with Covid. She said that her symptoms came on about 10 hours after the vaccination and were gone within 48 hours. Patient said that she does not know if having Covid so recently plays into it at all. Patient said that she received the last dose on 03Feb2021 at 1130. Patient said that the phlegm started in her throat and she had the chills. She woke up with the whole shebang. She stated that it got worse by the next day. She said that she did not feel a thing from the first injection and had no side effects. She never tested positive for Covid in Dec2020. Her mother ended up positive for Covid and she was exposed to her and showed symptoms. She had exhaustion vertigo, and general feeling of being unwell with Covid. She had all of that again, but she was told not to expect anything respiratory. She got concerned with the chest pain, cough, phlegm, and shortness of breath. She saw the doctor on 05Feb2021 and she was instructed not to take anything because it could affect the vaccine, but her symptoms went away within 48 hours. She said that she felt like the congestion felt like a allergic reaction for her, said that it was hard to swallow, and had a lot of phlegm in her throat. She said that it is not inherently different if you were allergic to flowers. Chest pain she described like you are full of phlegm and like there is inflammation. Shortness of breath: Feel panicky when you try to breath and you feel the phlegm. Patient said that when she gets sick she does have a tendency to get upper respiratory infections. Like with a cold that she would end up with a cough that would linger a little bit. She still thinks getting the vaccine was worth it. She just wished that it would have been a listed side effect, because when it is not, you panic. Most people are worried about the shortness of breath. She reported that her O2 levels were ok when she checked. Doctor gave her a vitamin IV to make her feel better. Told her that her lungs were clear and it was all upper respiratory.
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| 48 | 2021-02-24 | palpitations |
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega...
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Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
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| 48 | 2021-02-24 | hypertension |
Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chr...
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Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chronic HTN. Pt. was hypertensive. Pt. stated she felt better and was advised to go home and relax, check BP when rested, and check with primary care provider. If needs emergent attention go to nearest ER.
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| 48 | 2021-02-25 | palpitations | Palpitations, rapid breathing, difficulty breathing, refused transport by EMS |
| 48 | 2021-02-26 | heart rate increased, hypertension |
Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at th...
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Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at the time. Subsequent readings: BP 160/110 O2 Sat 95% HR 119 BP 196/120 O2 Sat 96% HR 125 Patient was transported to the hospital.
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| 48 | 2021-02-28 | hypertension | Developed high blood pressurein the days following the injection. Still being treated for it. |
| 48 | 2021-03-02 | loss of consciousness, blood pressure decreased |
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 ...
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after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
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| 48 | 2021-03-04 | chest pain |
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ...
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A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
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| 48 | 2021-03-04 | palpitations |
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif...
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About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
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| 48 | 2021-03-04 | chest discomfort | Chest tightness |
| 48 | 2021-03-05 | palpitations |
Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue ha...
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Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue has worsened and persists to this day. Acute onset of palpitations 48 hours after vaccine and lasting approximately 20 min., headaches lasting 3 days and severe heartburn lasting 3 days. Coarse fasciculations of left pectoralis muscle onset 50 hours after vaccine. This progressed over ensuring days to involve other muscles both above and below the diaphragm including gluteals, gastronemius muscles, abductor hallucis longus, left first dorsal interosseous, deltoids, triceps, various abdominal and spinal muscles, and more recently the left masseter. The fasciculations persist to this day. Muscle pains started 2 days after onset of the fasciculations and are moderate-severe and worsened by exercise. I experienced tingling at the lower limbs on 6 occasions and transient disorientation one day on my way to work. My vision has been a bit blurry at times. i have been moody and short-tempered at times.
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| 48 | 2021-03-05 | palpitations | Mild headache, tired, itchy eyes and face, sneezing, congestion, heart racing |
| 48 | 2021-03-07 | palpitations | Heart racing/sweating. Evaluated by EMS-Cleared |
| 48 | 2021-03-08 | chest pain, chest discomfort |
mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; C...
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mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
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| 48 | 2021-03-09 | loss of consciousness |
At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went...
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At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went into my bathroom to urinate. As I was using the restroom, I noticed my arm where I got the vaccine was very sore, and raised it slightly. Immediately after raising my arm, I became very dizzy and passed out, fell off of the toilet and hit the left side of my temple and eye on the marble ledge of my shower. As I came to, my whole body had chills and I was shaking. I applied a cold compress and took 2 Tylenol. I alternated between sweating and chills for the rest of the night. The next morning I had a headache and felt fatigued, but the dizziness had subsided and I rested.
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| 48 | 2021-03-09 | chest pain |
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne...
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Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
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| 48 | 2021-03-10 | heart rate increased, blood pressure increased |
Patient reported accelerated heart rate and a significant increase in blood pressure following the v...
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Patient reported accelerated heart rate and a significant increase in blood pressure following the vaccine
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| 48 | 2021-03-10 | lightheadedness | Vasovagal response - dizziness, vertigo. Improved with reclining and PO fluids. |
| 48 | 2021-03-10 | blood pressure increased |
anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a ...
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anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-03-11 | chest pain |
I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnose...
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I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnosed with Shingles.
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| 48 | 2021-03-11 | fainting |
Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated...
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Patient experience brief episode of syncope - blurry vision, dizziness and sweating that was treated with ice packs. Began at 4:50pm and resolved at 4:58pm
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| 48 | 2021-03-13 | chest discomfort |
Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were e...
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Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were extremely tight. By about 90 min slight wheezing and all over joint pain. Skin itching in various places. Took Benadryl. At night my whole body was tight muscled. Felt much better next day other than continued fatigue , sore arm and mild flu feeling. No fever or rash. The form
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| 48 | 2021-03-13 | palpitations, blood pressure increased, chest pain, heart rate irregular |
Relatively immediate onset of chest pain with elevated blood pressure above normal. Longer term res...
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Relatively immediate onset of chest pain with elevated blood pressure above normal. Longer term response was palpitations and irregular pulse limiting regular activity for just over one month. Cough and fluid accumulation in lungs began day 5 (similar to my presentation of Covid-19 infection but less intense). Regular exercise was able to resume approximately 2/26/21
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| 48 | 2021-03-14 | chest discomfort |
About an hour after receiving the vaccine, I developed a fever, body aches, headache and vertigo. D...
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About an hour after receiving the vaccine, I developed a fever, body aches, headache and vertigo. Day 2, I continued to experience these symptoms along with stuffy nose, cough, and tightness in chest. Day 3 (today), I am no longer have a fever, but continue to experience the other symptoms.
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| 48 | 2021-03-14 | hypotension | hypotension, nausea, lightheadedness |
| 48 | 2021-03-14 | heart rate increased, arrhythmia |
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ...
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out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
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| 48 | 2021-03-14 | palpitations, chest pain |
severe dizziness and palpitations with any change in posture- Postural Orthostatic Tachycardia Syndr...
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severe dizziness and palpitations with any change in posture- Postural Orthostatic Tachycardia Syndrome. was severe for 4 weeks but is still intermittently present 6 weeks later. I had to move a recliner to my clinic office to be able to get through my work day. could not stand for more than 5minutes without feeling that I would fall down. nausea x 2 weeks severe fatigue limiting activity x 4 weeks chest pain x 4 weeks (intermittent associated with tachycadia, no association with activity or food, pleuritic in nature, lasted 5-30 minutes at a time, no chest pressure, no sweating with it) I am better but not fully recovered.
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| 48 | 2021-03-15 | fainting |
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via ...
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2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82 HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
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| 48 | 2021-03-15 | palpitations |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-15 | blood pressure increased, heart rate increased | dizzy, nauseous, rapid heartrate, elevated blood pressure |
| 48 | 2021-03-16 | palpitations | Shaky, felt faint, hyperventilated Rash on neck Emt checked vitals Heart racing all else good |
| 48 | 2021-03-17 | heart rate increased, chest pain |
10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. ...
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10 minutes after shot first noticed increased pulse, then lips and tongue tingling/slight swelling. Throat tight. Some dizziness. Some chest pain. Some itching (especially scalp and sole of feet and then some on arms). Stayed where medical professionals could see me for about 2 hours. Took Benadryl about 3 hours later (after shot) and lingering symptoms mostly cleared up. 8 hours later still some itching and lips feel a little "off" still. Arm is normal vaccine sore. I have a strong history of repeated anaphylaxis (from MCAS) and this didn't get too serious compared to previous reactions I had to be hospitalized for.
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| 48 | 2021-03-17 | fast heart rate, hypertension |
Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocort...
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Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocortisone 0.1mg (pt took med prior to vaccine) No current outpatient medications on file. Allergies: Pt reports anaphylaxis x2 as a child after receiving vaccine (varicella and MMR) Not on File Medical history: "low blood pressure" per pt No past medical history on file. This was vaccine dose 0.3ml Pfizer Lot# ER2613 given @ 2:55pm Describe adverse reaction: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Employee was monitored for 30minutes. Vaccine @ 1455 and pt started to c/o "itchy throat" @ 1515. Pt requested water and was able to swallow w/o difficulty. C/o feeling dizzy and warm. VS continued to be taken while pt sat on gurney. MERT called @ 1527 and arrived @ 1534. Pt taken to ED. AOD present @ 1530 and escorted pt via gurney to ED w/ MERT @ 1540. A/O x3, following commands, RR 20's. No difficulty breathing. 15:21 128/86 100% RA HR107 RR20 15:27 157/84 100% RA HR100 RR20 15:33 125/85 100%RA HR114 RR20 Anaphylaxis symptoms: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Anaphylaxis plan: Anaphylaxis kit within reach. Pt also brought her own Epi pen. Not used. MERT called. Vasovagal symptoms: Dizziness Vasovagal plan: Pt remained seated and gurney brought to clinic. Administration error: NONE MERT called YES @ 1527 Transferred to ED VAERS report number: Email sent to OHS and patient documented in adverse reaction log.
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| 48 | 2021-03-17 | deep vein blood clot |
I received the first does of the Pfizer vaccine and within 24 hours had started developing a superfi...
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I received the first does of the Pfizer vaccine and within 24 hours had started developing a superficial thrombophlebitis on the inside calf of my left leg. By Sunday, February 28th, I was in the emergency room getting an ultrasound to rule out a blood clot. By March 11, I had developed a DVT. I have been put on blood thinner and had catscans, ultra sounds, and am under a physician's care weekly.
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| 48 | 2021-03-17 | chest discomfort |
Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 48 y.o. female who ...
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Progress Notes Nurse Practitioner COVID VACCINE CLINIC Subjective Patient is a 48 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience difficulty breathing, and chest tightness and phlegmy throat. . She denied rash, hives, welts, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, chest tightness and shortness of breath Previous Reactions: Covid shot : Muscle ache and headaches for 2 days. Objective Vitals Vitals: 03/17/21 1603 03/17/21 1639 03/17/21 1650 BP: 109/88 (!) 146/104 Pulse: (!) 117 (!) 107 SpO2: 99% 97% 99% Physical Exam Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Uvula midline. Eyes: General: Vision grossly intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased air movement present. Examination of the right-upper field reveals decreased breath sounds and wheezing. Examination of the left-upper field reveals decreased breath sounds and wheezing. Decreased breath sounds and wheezing present. No rhonchi or rales. Comments: Tight wheeze in lungs Cleared after 2 puffs of albuterol inhaler, symptoms reoccurred within 10 min of use. Neurological: Mental Status: She is alert. Psychiatric: Behavior: Behavior is cooperative. Pt was given albuterol inhaler 2 puffs,Pepcid, Benadryl IM and Solumedrol 125 mg IM. Pt initially clears for about 10 minutes, then airways tighten up again after inhaler use. Epinephrine 0.3 given and pt sent by AMR to hospital. O2 started at 2L at 4:50. Assessment/Plan Treatment included: albuterol, antihistamines, oral steroids, water and pepcid Follow up response to treatment: poor. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) 5:05 left for ER. Update given to AMR and SV ER. Electronically Signed 3/17/2021 4:56 PM
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| 48 | 2021-03-17 | chest pain, heart rate increased |
sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to othe...
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sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to other shoulder. next day, walking to garage-could not breathe, chest pain, heartrate elevated, 104 fever. ED-chest xray, EKG, blood work. 3-4 hrs. waiting for heart rate to go down. sent her home 103 fever. felt bad for 4 days after that-heart rate, fever. no Rx. otc Tylenol for fever. Doctor told her she should not have had vaccine since she recently had Covid.
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| 48 | 2021-03-18 | nosebleed |
Received vaccination on 3/16 at 11:00 am, first bloody nose on 3/17 at 7:15 am, second bloody nose o...
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Received vaccination on 3/16 at 11:00 am, first bloody nose on 3/17 at 7:15 am, second bloody nose on 3/19 at 7:00 am. No history of bloody nose.
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| 48 | 2021-03-18 | blood pressure increased |
Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because o...
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Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because of nurse negligence and human error she overdose me and injected two shots of vaccine one after the other at the same time. Right after the incident they shifted me to emergency and kept me under observation there for almost 10 hours. I am a healthy person of no underline issues but still went through physical and mental trauma. Right after the dose I got dizzy, disoriented, my BP shot up, my heart rate was on the lower side now I am moved to home but have severe body aches, headaches, ear pain and allergic rashes itch on both arms and neck . I am scared if this would affect my health in future.
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| 48 | 2021-03-19 | deep vein blood clot | Acute deep vein thrombosis of femoral vein of left lower extremity. |
| 48 | 2021-03-20 | very slow heart rate, hypertension |
Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I a...
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Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I am unable to give a detailed report due to this website expiring in 20 minutes. I will be more than happy to submit a complete timeline if needed.
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| 48 | 2021-03-21 | loss of consciousness |
After the patient received the Pfizer vaccine, she began to complain being dizzy. We gave her water,...
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After the patient received the Pfizer vaccine, she began to complain being dizzy. We gave her water, but afterwards, she began to lose conscious. We gave her 1 epinephrine (0.3 mg) dose, injected into her thigh. Thirty minutes later, the patient regained consciousness and was able to stand up and walk.
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| 48 | 2021-03-22 | loss of consciousness |
I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old f...
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I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot Number: EL3248), via an unspecified route of administration, administered in arm left on 05Mar2021 11:00 am as a single dose for COVID-19 immunization. Medical history included hypertension (blood pressure). The patient is not a pregnant. Concomitant medications in two weeks included ashwagandha taken for an unspecified indication, start and stop date were not reported, and blood pressure meds (unspecified). There is no other vaccine received in four weeks. The patient passed out Sunday night, 07Mar2021 23:00, she's not sure if it was related to the vaccine. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No Covid tested post vaccination. Therapeutic measures were taken for the AE. The outcome of event was recovered on an unspecified date in Mar2021.
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| 48 | 2021-03-23 | nosebleed | Nose bleed, hard to control |
| 48 | 2021-03-24 | pallor, chest discomfort |
Patient is a 48yo female presenting for her second COVID-19 Vaccine. She reported a prior reaction w...
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Patient is a 48yo female presenting for her second COVID-19 Vaccine. She reported a prior reaction with first dose of COVID-19 vaccine, with throat tightening and some chest tightness onset approximately 13 min after receiving the first vaccine dose. She took oral Benadryl and was monitored by EMS with complete resolution of symptoms after approximately 20 minutes. She did not require transport or hospital evaluation but saw her allergist for evaluation prior to presenting today for second dose. She was advised by her allergist to proceed with second dose of vaccine given her comorbidities and risks associated with COVID-19 infection. This medical evaluator reviewed risks with her, and possibility for allergic/adverse reaction with her second dose of the vaccine, and she chose to proceed with vaccine. She was initially doing well and was positioned next to EMS for close monitoring. Approximately 20-25 minutes after receiving second dose of the vaccine, she started to have a dry persistent cough, with some upper airway wheezing, no stridor or retractions, with auscultated normal breath sounds and good air exchange however with noted slight increase in respiratory effort and pale skin color, no diaphoresis. She took oral benadryl 25mg at 11:27am, but cough persisted and she developed lightheadedness and was transferred to the ambulance from her personal vehicle.10L oxygen was placed by nasal cannula. Within a few minutes, cough improved and skin color improved. Breath sounds continued to be clear with good air exchange. No wheezing or stridor or retractions were noted during this evaluation. She was transferred to another stretcher and oxygen removed, to allow for transport to the hospital via another ambulance. Within a few minutes off oxygen, cough returned. She was then transferred to local hospital for further monitoring and evaluation.
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| 48 | 2021-03-24 | blood pressure increased, blood pressure decreased, heart rate increased, palpitations, chest discomfort |
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and...
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anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
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| 48 | 2021-03-24 | chest pain, inflammation of the pericardium |
early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the...
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early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL1283, unknown expiration), via an unspecified route of administration in left arm on 13Jan2021 at 13:00 (01:00 PM; at the age of 48 years old) at a single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient has no known allergies. The patient also received first dose of BNT162B2 (Brand: Pfizer; Lot number: EJ1685, unknown expiration) on 23Dec2020 at 01:00 PM in left arm (at the age of 48 years old) for COVID-19 immunization. The patient went to the ER with severe chest pain. After many tests were run, doctors believed that the patient was in early stages of pericarditis or the shingles on 17Feb2021 at 04:00 AM. The patient confirmed that she never developed shingles but have had all symptoms of pericarditis. The events resulted in emergency room/department or urgent care visit. The patient received NSAIDs and pain meds as treatment for the events. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event pericarditis is unrelated to BNT162B2 vaccine, but more likely an inter-current medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-03-25 | chest discomfort, hypertension |
Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 9...
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Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 99% O2 sat.
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| 48 | 2021-03-25 | hypertension |
Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling diz...
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Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling dizzy, warm, hear raising and not feeling right. A team alert was called and at 14:30 healthcare team arrived to provide assistance. Patient's blood pressure was up and was taken by team to medical office for further evaluation.
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| 48 | 2021-03-25 | vaginal haemorrhage |
Within a short time after receiving my COVID vaccination, I experienced a burst of energy, pretty se...
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Within a short time after receiving my COVID vaccination, I experienced a burst of energy, pretty severe abdominal cramping, and vaginal bleeding (small amount; very close location-wise to being internal but was external). Bleeding lasted until bedtime and was gone, along with the abdominal cramping and burst of energy by the next morning and has never returned. Vaccine #2 was on 2/9/21 and the only difference I felt after that one was tiredness; took a 3 hour nap shortly after I returned home and never noticed anything else since. (Not sure if this helps to know...I had a hysterectomy mid-October, 2020.)
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| 48 | 2021-03-26 | palpitations |
03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flu...
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03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flush of heat over my body. After about 3 minutes heartbeat regulated and flush of heat dissipated. About 45 minutes later I got a headache last about 15 minutes. Then came back about an hour later lasting same time before stopping. This occurred again about 3 hours later, same as before. 03/24/2021 - arm was sore and injection site was slightly itchy and hot but stopped by 03/25/2021, no hunger. 03/24/2021 - woke up feeling nauseous and overall crappy feeling (not achy, not in pain). nausea lasted throughout the day, but no vomiting. headache often throughout the day but not lasting more than 10-15 minutes, no hunger. 03/25/2021 - again woke up feeling nauseous lasting off/on thru day, no vomiting, no headache, feeling overall more energetic wanting to eat when nausea went away. 03/26/2021 - woke up NO nausea, not hungry so ate later in afternoon. Within 20 minutes of me eating I became extremely fatigued, dizzy and could barely stand up. I started to feel like I was going to faint and got to a couch and laid down. I started sweating and felt like my body was on fire. My scalp and face were wet with sweat, I felt dizzy and extremely nauseous before I vomited (3) times. After vomiting the dizziness, nausea and weakness dissipated. After about 30 minutes I just felt tired and my chest hurt from the convulsions of vomiting. After about 2 hours I felt better and just tired. 03/27/2021 - woke up no nausea, no headache and slightly fatigued.
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| 48 | 2021-03-26 | heart rate increased |
I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscl...
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I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscle spasms near my right ankle. I was examined by the Physician and EMT on site. The following day, I experienced body and head aches. Naproxen and Tylenol
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| 48 | 2021-03-26 | heart rate increased |
I have had a rapid heart rate and it only happens when I am sleeping or lying down. I also have a co...
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I have had a rapid heart rate and it only happens when I am sleeping or lying down. I also have a covid arm that has not went down.
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| 48 | 2021-03-31 | arrhythmia |
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in fa...
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started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-04-07 | cerebrovascular accident |
03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/2...
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03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/26/2021 around 9:40AM broke window to get inside the apartment. Called ambulance, went to hospital, around 3:00PM transferred to other hospital and still there now. NO previous strokes Doctors have denied that the stroke is due to COVID 19 second vaccine. They also said that she will never be able to communicate but we have her on video. She has lying on her floor for 16 hours. The hospital also punctured her lung by inexperienced care givers trying to insert a feeding tube into her nostrils.
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| 48 | 2021-04-07 | cerebrovascular accident |
Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient rec...
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Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, intramuscular, administered in right arm on 24Mar2021 13:00 (Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6202) at the age of 48-year-old, on 03Mar2021 at 12:00 PM intramuscularly administered as the left arm for COVID-19 immunization. The patient experienced stroke on 25Mar2021 15:00. The event resulted in emergency room visit and the patient was hospitalized on an unspecified date for 6 days. It was unknown if treatment was given. The event was also reported as life-threatening and disabling/incapacitating. The outcome of the event not recovered.; Sender's Comments: A causal relationship between the event stroke and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is possible based on the information provided, drug profile and a temporal association in this 48-year-old female patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-04-09 | hypotension, palpitations |
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h...
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3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
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| 48 | 2021-04-09 | loss of consciousness |
passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on...
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passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on head that is swollen and bruised; cut on my left side of neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533), via an unspecified route of administration in left arm on 24Mar2021 at the age of 48 years old at a single dose for COVID-19 immunisation. Medical history included asthma controller, anxiety. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergy. Approximately 15hrs after receiving vaccine, On 25Mar2021 at 01:15, patient had severe dizziness with nausea feeling sat down and then passed out waking up after (unknown length of time) on the floor. Patient stated "i had struck my head and my left neck/shoulder on table and wall. Now I have huge knot on head that is swollen and bruised and a cut on my left side of neck." Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered. Follow-up Information has been requested.
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| 48 | 2021-04-11 | very slow heart rate, hypotension, fainting |
Recipient had a syncopal episode. Recipient was seen by on-site EMS - was bradycardic and hypotensiv...
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Recipient had a syncopal episode. Recipient was seen by on-site EMS - was bradycardic and hypotensive and had a 2nd syncopal episode. Patient was transferred to the hospital by ambulance for complete evaluation.
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| 48 | 2021-04-12 | transient ischaemic attack |
mini stroke; having vision issues; having vision issues, she could not focus and started seeing flas...
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mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-04-15 | deep vein blood clot |
DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week lat...
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DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.
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| 48 | 2021-04-15 | oxygen saturation decreased, heart rate increased, blood pressure increased |
She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was b...
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She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was beating fast; Blood pressure was up; This is a spontaneous report from a contactable consumer (Patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown) via unspecified route of administration in the right arm on 28Jan2021 13:20 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Hashimoto's disease (for about 20years), Breast cancer (had her five year clearance recently) and AFib (She had AFib two years ago because she was on too high of a dose) from an unknown date. Concomitant medications included ongoing Levothyroxine Sodium (Tirosint) at 175ug daily for hashimoto's disease and Liothyronine at 5ug daily for hashimoto's disease. Family history included her son had a reaction to a vaccine, but she is not sure which vaccine it was. His arm was swollen, red, hot, and painful after the vaccine. The patient has not tested for COVID-19 prior to vaccination and not since vaccination. The has not taken any Pfizer vaccine previously and not taken any other vaccine on the same day. The patient experienced adrenaline rush, heart was beating fast, blood pressure was up and felt agitated from 01Feb2021. She had the Pfizer vaccine on 28Jan2021 and four days later at work she felt like she had an adrenaline rush that lasted for 3 hours. It felt like her heart was beating fast, her blood pressure was up, and she felt agitated. It was unusual. It seemed to stop and she went to sleep at 20:00. She woke up at 22:00 and her heart was beating out of her chest and she felt like she couldn't breathe. Her Apple watch showed her heart was beating at 140 sitting still. She went to the hospital. It stopped after 45 minutes, maybe an hour. Her oxygen level was low when she got to the hospital. It was 92 and her blood pressure was up. She has just a higher level of agitation. She is not sure if that is the immune system. She snapped at someone at work and she has never done that. Her heart rate and blood pressure have resolved completely. The agitation is still there. She went to the ER on 02Feb2021. It resolved in the ER, so she was not admitted. She had no more racing heart that day. Her blood pressure was up in the ER. The agitation comes and goes. She gets that way when her adrenaline is going, if her blood pressure is up, or if she takes a steroid. Any kind of adrenaline reaction. She hasn't used them for so long. She did not reacting well to it. They checked her thyroid level. She had AFib two years ago because she was on too high of a dose. She was on the same brand of Tirosint, but higher dose. The dose may have been 200mg but she is not sure. She is not absolutely sure what dose she was on at that point. She wasn't on Liothyronine at that time. The patient visited the emergency room as she thought she was having a heart attack. It scared her. she is going to talk to her cardiologist to make sure it is ok for the second dose. The outcome of the events heart was beating fast and Blood pressure was up recovered, the outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-04-15 | blood pressure increased |
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu...
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Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
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| 48 | 2021-04-16 | loss of consciousness |
Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vo...
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Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21.
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| 48 | 2021-04-16 | blood pressure increased |
Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontane...
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Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontaneous report from a contactable physician, the patient. A 48-year-old female patient (non pregnant) received dose number 1 of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9264) via an unspecified route of administration on 09Feb2021 at 12:15 PM(at 48-year-old ) in left arm as a single dose for COVID-19 immunization. Medical history included Hypertension (well controlled prior) and glaucoma. Patient had known allergies of cephalosporins. Concomitant medications included Diovan, Biotin, Vitamin D, Magnesium and Glucosamine (within two weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 03:00 AM, rising blood pressures started overnight that led to doubling of Diovan dose, then switch to a different agent, followed by ER visit on 13Feb2021 for BP 175/103 and another medication was added and experienced persistent headache as well. Both symptoms persist at this time. New medication for BP control were given, EKG and labs done. Outcome of the event was not recovered.; Sender's Comments: A contributory role of vaccine BNT162B2 to the event rising blood pressures cannot be fully excluded based on the close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-04-17 | deep vein blood clot, blood clot |
Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contac...
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Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old non -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48 years, via an unspecified route of administration, administered in the left arm on 01Apr2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient has no medical history. Patient has not had Covid prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced blood clot DVT in left leg on 02Apr2021 at 09:00. Treatment for the event includes blood thinners. It was reported that the AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included nasal swab for covid test on 02Apr2021 which had a negative result. The outcome of the event was not recovered. Information about Lot/batch number is requested.
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| 48 | 2021-04-17 | fainting |
Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consu...
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Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-04-17 | vaginal haemorrhage |
However, the day after my injection I had light bleeding for 5 days which required light tampons to ...
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However, the day after my injection I had light bleeding for 5 days which required light tampons to control; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8732), via an unspecified route of administration, administered in left arm on 27Mar2021 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included vitamins nos. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient started a light period on Sunday which continued for 5 days. She had a Mirena IUD for almost 7 years (second one inserted 2 years ago). She don't have a period with Mirena; every couple months she will spot for a day but it does not require a tampon. However, the day after her injection she had light bleeding on 28Mar2021 for 5 days which required light tampons to control so it didn't ruin her clothes. Treatment was not received for the event. The outcome of the event was recovered. Event was reported as non-serious.
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| 48 | 2021-04-20 | loss of consciousness, excessive bleeding |
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin...
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became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
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| 48 | 2021-04-24 | heart rate increased |
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho...
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Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
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| 48 | 2021-04-26 | transient ischaemic attack |
I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and...
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I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a spontaneous report from a contactable consumer patient. This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021.Outcome of the events was recovering.
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| 48 | 2021-04-28 | deep vein blood clot |
Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactabl...
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Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration, administered on the right arm, at the age of 48 years, on Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included vitamin b complex (VITAMIN B); astragalus mongholicus (ASTRAGALUS 6000); lysine (LYSINE) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient developed a blood clot in peroneal vein of left leg on 02Apr2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Therapeutic measures (blood thinners) were taken as a result of developed a blood clot in peroneal vein of left leg. The outcome of the event was recovered with sequelae.
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| 48 | 2021-04-30 | loss of consciousness |
Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and ...
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Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
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| 48 | 2021-05-04 | blood clot |
took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals...
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took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals; Nausea; she wanted to make sure her not feeling well was normal; She had a really bad headache. Clarifying the headache started 1-2 hours after she got the first COVID-19 Vaccine shot; her (left) arm was really sore after she had the COVID-19 Vaccine, but she had expected that; She was still achy in her muscles, but not everywhere. She said her muscles ached from her shoulders up only.; she had a scratchy (sore) throat; she felt tired; she had a little bit of congestion; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a swollen lymph node in her left arm pit for the last couple days; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a pressure inside of her head/Her head doesn't feel well. She said she does not quite have a headache, but her head does not feel normal.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0170), dose 1 single dose via an unspecified route of administration in the left arm on 16Apr2021 between 3:53 PM-3:55 PM (at the age of 48 years-old) for COVID-19 vaccination. Medical history included hypermobility syndrome from an unknown date and unknown if ongoing, tends to get headaches with her hypermobility issues, and those headaches felt like pain in her head. Reported she was on the hypermobility spectrum with tension headaches, vertigo positional from an unknown date and unknown if ongoing, 3-4 weeks prior to getting the COVID-19 Vaccine, she tried to take a half of a beta blocker pill to treat the benign paroxysmal positional vertigo (BPPV). She said the BPPV had cleared, and she felt better, vestibular migraine from an unknown date and unknown if ongoing had some residual dizziness from the vestibular migraines, Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. She said she did not have a technical diagnosis for Ehlers-Danlos Syndrome (hypermobility) yet, and finally sees a geneticist next month. She said she was on the weaker end of the Ehlers-Danlos hypermobility spectrum disorder, and did not have a definitive diagnosis. She didn't drink alcohol, exercised every day and slept enough. The patient did not receive any previous immunization with the Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Cyanocobalamin and ergocalciferol were discontinued a week before she got the COVID-19 vaccine to avoid any issues.The patient experienced she had a little bit of congestion on Apr2021, she wanted to make sure her not feeling well was normal on 16Apr2021, she had a really bad headache, clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot on 16Apr2021, her (left) arm was really sore after she had the covid-19 vaccine, but she had expected that on 16Apr2021, she had a swollen lymph node in her left arm pit for the last couple days on Apr2021, after she received the covid-19 vaccine that she had some clotting, and menstrual irregularities on Apr2021, she had a pressure inside of her head/her head doesn't feel well, she said she does not quite have a headache, but her head does not feel normal on Apr2021, she was still achy in her muscles, but not everywhere. she said her muscles ached from her shoulders up onlyon 16Apr2021, she felt off/felt a little run down on Apr2021, she had a scratchy (sore) throat on Apr2021, she felt tired on Apr2021, nausea on 16Apr2021, her (left) arm was really sore on an unspecified date and swollen lymph node in her left arm pit on an unspecified date. She said it was not possible that her head pressure, and her head feeling off had anything to do with the BPPV or the vestibular migraines. She said her ear crystals had fell out since then, and what she was experiencing now must be due to the COVID-19 Vaccine. She had no fever. She only had nausea for the first 24 hours after getting the COVID-19 Vaccine. She said she had no vomiting. She said her headache had been constant since she had the COVID-19 Vaccine on 16Apr2021. The headache started 1-2 hours after she got the first COVID-19 Vaccine shot. The events did not require an emergency room or physician's office visit. The patient underwent lab tests and procedures which included blood test and urine analysis on an unknown date in Mar2021 or Apr2021: came back normal . Therapeutic measures were taken as a result of she had a really bad headache. clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot (headache). She took 2 generic Whole Foods 365 brand Acetaminophen 500mg (1000mg total): NDC Number: 42681-7076-1, Lot Number: 8HE1354B, & Expiration Date: Jun2020 in Apr2021. The events did not require an emergency room or physician's office visit. The clinical outcome of not feeling well, headache, arm was really sore, swollen lymph node, had some clotting and menstrual irregularities was recovering and not recovered for pressure inside of her head, felt off, scratchy (sore) throat , congestion, felt tired, hadn't felt 110%, recovered for nausea and unknown for achy in her muscles and ear crystals.
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| 48 | 2021-05-07 | heart rate increased |
Shortness of breath; Dizziness; A fast heartbeat; This is a spontaneous report from a contactable co...
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Shortness of breath; Dizziness; A fast heartbeat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9269) on 05Feb2021 18:15 at left arm at single dose for COVID-19 immunization. Medical history included known allergies was Dust, mold, cat. Patient is not pregnant. Concomitant medication was not reported. Patient experienced shortness of breath, dizziness and a fast heartbeat, all on 05Feb2021 10:30 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was recovered from the events in Feb2021. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-07 | pulmonary embolism, heart rate increased, hypertension |
high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spo...
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high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spontaneous report from the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the right arm on 04Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient's known allergies included morphine, hydromorphone (DILAUDID), sulfas, and coconut. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via unspecified route in the right arm on 14Jan2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 19Apr2021, the patient was having high heart rate, high blood pressure and shortness of breath. She was hospitalized and diagnosed with bilateral pulmonary emboli. The events resulted in emergency room/department or urgent care and hospitalization for 3 days. The patient stated that she doubts this was vaccine related but wanted to report it. The patient was treated with intravenous heparin, then oral rivaroxaban (XARELTO). The clinical outcome of the events high heart rate, high blood pressure and shortness of breath, and bilateral pulmonary emboli was recovering. The patient was tested for COVID post vaccination via nasal swab on 19Apr2021 with result of negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Investigators, as appropriate.
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| 48 | 2021-05-10 | blood clot |
swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ...
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swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.
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| 48 | 2021-05-11 | blood pressure increased |
Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chill...
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Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chills; Exhaustion; Body aches; Stomach ache; Diarrhea; Coughing; Headache; Short of breath; Elevated blood pressure; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 08:45 (Batch/Lot Number: EN8730) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6206, administration time: 08:45 AM) for COVID-19 immunization. On 18Apr2021 at 12:00, the patient experienced fever, chills, exhaustion, body aches, stomach ache, diarrhea, coughing, headache, short of breath, elevated blood pressure. The patient underwent lab tests and procedure which included 2 negative COVID tests on 19Apr2021 and 23Apr2021 respectively and flu test: negative on an unspecified date. The patient was diagnosis of COVID (despite negative test) received on 23Apr2021. The events resulted in emergency room/department visit or urgent care. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 48 | 2021-05-11 | nosebleed |
tiredness; headache; nausea; feeling of her lungs swelling and expanding in her thorax; terrible bac...
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tiredness; headache; nausea; feeling of her lungs swelling and expanding in her thorax; terrible back pain; dry and bloody mucus in her nose; dry and bloody mucus in her nose; bloody mucus from her mouth; chills; fever; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 22Apr2021 as a single dose for COVID-19 immunization. Medical history included menstrual irregularity and tear meniscus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received he first dose of BNT162B2 (lot number: ER8737) on 31Mar2021 on 24:00 on the left arm for COVID-19 immunization and after 8 days, the patient had scleritis. It was reported that on 22Apr2021 at 23:45 the same day that the patient received the second dose, she had chills and fever. The next day, 23Apr2021, the patient had tiredness, headache, nausea, feeling of her lungs swelling and expanding in her thorax and terrible back pain. The patient could not use a bra for two days, there was bloody mucus from her mouth, dry and bloody mucus in her nose. The patient stated that all side effects stayed for two days except for the fever which was only for one and a half. The patient was tested for any cause of sickness in the blood test on an unknown date and everything was negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization on an unspecified date. The patient received prednisolone eye drops and Atrophine sulfate eye D as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 49 | 2021-01-03 | chest discomfort |
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency,...
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Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
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| 49 | 2021-01-03 | fast heart rate |
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou...
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Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
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| 49 | 2021-01-04 | chest pain |
I had left chest wall pain (lateral) while breathing and laughing. I don't believe it was muscular...
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I had left chest wall pain (lateral) while breathing and laughing. I don't believe it was muscular.
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| 49 | 2021-01-04 | palpitations |
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af...
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I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
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| 49 | 2021-01-05 | heart rate increased |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | palpitations, blood pressure increased |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | blood pressure increased |
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine admi...
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Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
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| 49 | 2021-01-05 | fainting |
bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happ...
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bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.
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| 49 | 2021-01-05 | chest discomfort, hypertension, heart rate increased |
coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and...
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coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.
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| 49 | 2021-01-05 | blood pressure increased |
periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than...
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periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO
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| 49 | 2021-01-06 | increased heart rate |
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed...
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12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
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| 49 | 2021-01-06 | chest pain, chest discomfort |
About an hour after the injection I had pain and burning going down my left side and in the left sid...
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About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
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| 49 | 2021-01-06 | fast heart rate |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | chest discomfort |
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci...
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This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
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| 49 | 2021-01-06 | blood pressure increased |
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i...
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Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
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| 49 | 2021-01-06 | palpitations, fast heart rate |
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ...
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a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | fast heart rate, palpitations |
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Ta...
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she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
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| 49 | 2021-01-07 | palpitations, fast heart rate |
01/08 sent email to cancel the second dose. I called her and she states after the first dose after ...
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01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.
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| 49 | 2021-01-07 | hypertension, fast heart rate |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | fast heart rate |
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove...
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Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
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| 49 | 2021-01-07 | fast heart rate, blood pressure increased |
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1...
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Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
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| 49 | 2021-01-07 | chest discomfort |
Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarr...
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Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; This is a spontaneous report from a contactable health care professional nurse, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) in the left arm on 22Dec2020 14:30 as a single dose, for COVID-19 immunization. Medical history includes Lupus, Endometriosis, Epilepsy from an unknown date and unknown if ongoing. Concomitant medication included belimumab (BENLYSTA), prednisone (PREDNISONE), topiramate (TOPAMAX), levetiracetam (KEPPRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], Sulfa Drugs and hibiclens and experienced drug hypersensitivity. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient experienced sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea on 23Dec2020 07:00. Events continues through now 10 days later and still feel horrible. The events resulted in a physician office visit. The patient underwent lab tests that included SARS-CoV-2 test Nasal Swab (Both rapid and PCR) on 30Dec2020; influenza test and Streptococcus test on an unspecified date. The results of all laboratory tests influenza Streptococcus test and COVID (Both rapid and PCR) were negative. No treatment was received given for the events. The clinical outcome of sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea was not recovered.
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| 49 | 2021-01-08 | hypertension |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | hypertension | Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins |
| 49 | 2021-01-08 | chest pain |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | fast heart rate |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-09 | blood pressure increased |
I received COVID 19 Pfizer vaccine on 12/23/20 and on 12/27/20 my blood pressure started to spike wi...
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I received COVID 19 Pfizer vaccine on 12/23/20 and on 12/27/20 my blood pressure started to spike with readings 150's/100's while well controlled on medication- Metoprolol 25 mg tab daily. My BP remained elevated on 12/28 and i subsequently went to the ER and had chest XRay; EKG and cardiac workup done with all tests negative. I was instructed by ER Doctor to follow up with my cardiologist- Dr. and he subsequently changed my medication regimen to Metoprolol 25 mg tab twice daily. Since that episode my BP has been well controlled. I am not sure if there is a correlation with the vaccine. However i am bringing to your attention as i have never had a spike in BP while on BP meds.
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| 49 | 2021-01-10 | chest discomfort | Fever, fatigue , chest heaviness, cough. Treatment: Robutussin, Motrin. Fever and fatigue improved. |
| 49 | 2021-01-10 | palpitations |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-11 | hypertension |
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by...
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Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
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| 49 | 2021-01-11 | hypertension |
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness...
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The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
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| 49 | 2021-01-12 | heart rate increased, palpitations |
"Information regarding possible side effects I found to be odd. I experienced heart palpitations the...
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"Information regarding possible side effects I found to be odd. I experienced heart palpitations the day after the injection until today. This continued in episodes for 48 hours. I also experienced an increase in HR. I usually have a pulse of around 70-74. Post injection it stayed at 94-95 for an entire day with the palpitations."
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| 49 | 2021-01-12 | chest discomfort |
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels ...
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Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
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| 49 | 2021-01-12 | chest discomfort | Reported feeling flushed and experienced chest pressure. Transferred to ED |
| 49 | 2021-01-13 | fast heart rate, chest discomfort |
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches...
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1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
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| 49 | 2021-01-13 | heart rate increased |
Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of ...
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Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of 135 bpm.
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| 49 | 2021-01-13 | heart rate increased |
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery...
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felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
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| 49 | 2021-01-13 | palpitations, fast heart rate |
heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, feve...
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heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, fever and myalgia x 6 hours; next day, general myalgia only
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| 49 | 2021-01-14 | chest pain |
At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of ...
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At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of breath prompting a trip to the Emergency Department. A chest CT Angio to rule out pulmonary embolus was done and negative for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04). Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.
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| 49 | 2021-01-14 | blood pressure increased |
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i...
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Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
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| 49 | 2021-01-14 | chest pain |
Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided...
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Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided Chest pain with difficulty breathing. Patient's chest pain was so bad she thought she was going to die. Was transported to ER via ambulance, had cardiac workup, blood clot workup (had left leg pain the day before incident). Was discharged home on zanaflex and motrin with diagnosis of Chest Wall pain about 4 hours later. Follow up on 1.15.2021 at 1000 and patient doing better but still has chest pain. Will not be getting 2nd COVID vaccination.
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| 49 | 2021-01-15 | heart rate increased, palpitations |
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz...
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Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
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| 49 | 2021-01-16 | lightheadedness |
Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appet...
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Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appetite. Lasted over 4 hs severe, 12 hs moderate
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| 49 | 2021-01-17 | loss of consciousness |
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp...
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headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
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| 49 | 2021-01-18 | palpitations |
10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl...
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10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.
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| 49 | 2021-01-18 | fast heart rate |
Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a ...
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Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies. On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 49 | 2021-01-18 | blood glucose increased |
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my...
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Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
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| 49 | 2021-01-19 | blood clot |
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte...
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"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
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| 49 | 2021-01-19 | blood pressure increased |
Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny ...
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Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny nose. Day 4, nose runny like a faucet and cough. Day 5, runny nose, sore throat, coughing a lot. Took some Theraflu. Day 6, no more sore throat but coughing and some shortness of breath on exertion and at rest. Day 7, coughing, nose not running as much, shortness of breath still present. Day 8, shortness of breath, coughing a lot. Day 9 (Tuesday, January 19, 2021) still coughing and experiencing Shortness of breath. Texted my manager and explained whatvhad been going on since I got the second vaccine and that I wasn't sick prior to getting it. And that no other family member in my home was sick besides me. She put me in touch with the HR director who scheduled n e for a COVID test that same night. I went to have the test done and also had the ER doctor to evaluate me because I was feeling so bad with the coughing and Shortness of breath. Today, I am still coughing, producing nasal drainage, and feeling short of breath at times.
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| 49 | 2021-01-19 | blood pressure increased, chest discomfort | Tongue swelling, throat and chest tightness |
| 49 | 2021-01-19 | chest discomfort |
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens...
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generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
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| 49 | 2021-01-19 | chest discomfort, lightheadedness |
he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mi...
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he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
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| 49 | 2021-01-20 | blood clot |
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot bu...
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Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-20 | heart rate increased, palpitations |
Patient has had a history of an egg allergy as a kid, so she takes prednisone prior to flu immunizat...
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Patient has had a history of an egg allergy as a kid, so she takes prednisone prior to flu immunizations to reduce any signs of allergic reaction. To prepare for this vaccine, she premedicated with prednisone from Monday-Friday. While sitting in observation, she notice that her heart was racing- at that time her heart rate was 132 bpm, and she was advised to go to the ED for further evaluation. Upon arrival at ED, her HR had reduced to 106 bpm at 0958. She was monitored and discharged at 1013 at which point to returned to work as a nurse without problem.
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| 49 | 2021-01-20 | palpitations, fast heart rate | anxiety, tachycardia, palpitations. all symptoms resolved during observation period of 30 minutes. |
| 49 | 2021-01-20 | chest discomfort, heart rate increased |
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches...
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fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-21 | fast heart rate | Achy arm Body Aches Fast heart beat |
| 49 | 2021-01-21 | palpitations |
Fatigue, shortness of breath, headache, heart palpitations, muscle aches, joint pain, all of these f...
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Fatigue, shortness of breath, headache, heart palpitations, muscle aches, joint pain, all of these for 8 days after then low grade fever 99.6 for 24 hours after other symptoms improved. Left with unusual fatigue during normal activities.
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| 49 | 2021-01-21 | loss of consciousness, hypotension |
High Fever of 104 degrees F for a duration of 18 hours, Orthostatic Hypotension with Bp as low as 63...
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High Fever of 104 degrees F for a duration of 18 hours, Orthostatic Hypotension with Bp as low as 63/40 in supine for a duration of 18 hours, repeated loss of consciousness due to low BP
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| 49 | 2021-01-21 | palpitations, chest discomfort, skin turning blue |
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ...
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Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
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| 49 | 2021-01-21 | heart rate increased, chest discomfort |
Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I ...
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Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I feel short of breath. I have pounding in my chest. I got dizzy after a bath and almost fell. I am very well hydrated I have drank at least 2 liters of water. I can?t get rid of my headache or body aches. I have taking ibuprofen , Pepcid , zomig for my headache which didn?t help , 600 mg of gabapentin, 20 of prednisone .. I feel like I can?t get enough air.
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| 49 | 2021-01-24 | hypertension, heart rate increased | High heart rate, hypertension |
| 49 | 2021-01-25 | heart rate decreased |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | chest discomfort | Fever, headache, very bad body aches, chest pressure, dizziness and missed two days of work |
| 49 | 2021-01-26 | palpitations |
Patient c/o palpitations after receiving 2nd COVID vaccine. Her HR was 140-160. No CP, no SOB or diz...
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Patient c/o palpitations after receiving 2nd COVID vaccine. Her HR was 140-160. No CP, no SOB or dizziness. Went down to 86 and she felt better and left the clinic. she returned to the clinic 20 minutes later c/o palpitations again. Her HR was then 112. Transported to ED for eval and treatment.
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| 49 | 2021-01-26 | chest discomfort |
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ...
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Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
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| 49 | 2021-01-27 | chest pain |
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable...
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Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
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| 49 | 2021-01-27 | hypertension | My blood pressure went up all the way to 197/139 |
| 49 | 2021-01-27 | palpitations |
Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes afte...
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Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes after injection. Patient noted that symptoms were mild and were improving. She declined EMS services/hospital evaluation and elected to go home after appx. 30 minutes of observation. HR and BP were both within normal limits.
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| 49 | 2021-01-27 | chest pain, chest discomfort |
Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon wi...
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Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon with generalized body aches. By early evening left arm tightness radiates to shoulder/shoulder blade/left chest and arm tingling sensation (as if pulled muscle) requiring icing area and Motrin; felt tired and lethargic; woke up Sunday with headache, ate breakfast and went back to bed till 2pm. Felt better as day progresses Sunday. Wednesday 1/27/21 left arm sore as if I received injection that morning. as day progresses soreness radiates to the shoulder and chest area, tingling resumes and by evening with numbness and nausea. Thursday 1/28/21 still with the tingling sensation and whole left upper arm and shoulder area tight with some weakness.
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| 49 | 2021-01-28 | hypertension |
BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse ...
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BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | palpitations, blood pressure increased |
PT stated had not eaten breakfast or lunch today. Received tragic news prior to appointment. 5 min a...
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PT stated had not eaten breakfast or lunch today. Received tragic news prior to appointment. 5 min after vaccination felt dizziness heart racing ,pulse 96, 2:05 pm BP 158/80 Pulse-87, SP02 97% RR 12 2:06 pm. Given crackers and water. 2:30 pm BP 138/80 P 78 Pulse ox 98% RR 12. Patient feeling better "normal" agreeing to wait for 25 more minutes. 2:55 pm. Patient feeling well instructed to call 911 if symptoms recur or worsen.
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| 49 | 2021-01-28 | heart rate increased |
Patient had increased heart beat, sweating and dizzy. Was transported to ER where she was administer...
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Patient had increased heart beat, sweating and dizzy. Was transported to ER where she was administered Benadryl IV for 15 minutes. She was then realesed and followed up by primary care. Was prescribed Alprazolam 0.5mg bid and Naproxen 500 bid. Patient feels fine now.
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| 49 | 2021-01-28 | palpitations |
Started with low grade fever 99.8, throbbing headache, muscle aches, chills, this happened 1/28 6 pm...
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Started with low grade fever 99.8, throbbing headache, muscle aches, chills, this happened 1/28 6 pm , then took some ibuprofen. Hardy time sleeping. Next day 1/29 fever 100.4, chills, increased muscle aches, headache still and now heart palpitations. Took ibuprofen again, but not much relief.
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| 49 | 2021-01-30 | blood pressure increased |
My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feelin...
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My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feeling. Had to take BP meds again n lay down, seemed to go down after an hour of taking BP meds to 140/89
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| 49 | 2021-01-31 | chest discomfort, chest pain |
. In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermitte...
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. In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; local pain/bodyache; Fatigue; feverish feeling; dry cough; This is a spontaneous report from a contactable Physician (patient). A 49-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 08Jan2021 11:00 at single dose at left arm for covid-19 immunisation . Medical history included bee sting. There were no concomitant medications. The patient previously received the first dose bnt162b2 on 18Dec2020 10:30 AM at Left arm. The patient experienced a retrosternal chest discomfort, scratchiness, tightness that has been intermittent, local pain, bodyache, fatigue, feverish feeling, dry cough on 08Jan2021. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 26Aug2020. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; Information on the Batch/Lot number has been requested.
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| 49 | 2021-01-31 | fast heart rate, fibrin d dimer increased, pulmonary embolism |
Patient began having increasing shortness of breath about a week after receiving first dose of Pfize...
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Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine. Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation. Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%. On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally including segmental branches without evidence of right heart strain.
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| 49 | 2021-02-01 | blood pressure increased, fibrin d dimer increased, chest pain, fast heart rate, palpitations |
Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycar...
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Pain at site; shortness of breath; palpitations; elevated blood pressure; positive D-dimer; tachycardia; abnormal ekg; headache; chest pain; achy; fatigue; fever; chills; Covid/Flu like symptoms; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 11Jan2021 at 13:00 at single dose in left arm for covid-19 immunization. Medical history included hypothyroidism, known allergies: penicillin and dexamethasone. Concomitant medication included thyroid (ARMOUR THYROID), lisdexamfetamine mesilate (VYVANSE), amitriptyline, zolpidem. The patient previously received the first dose bnt162b2 (lot number: EK5730) on 21Dec2020 at 13:00 in left arm for covid-19 immunization. The patient experienced pain at site, shortness of breath, palpitations, elevated blood pressure, positive D-dimer, tachycardia, abnormal EKG, headache, chest pain, achy, fatigue, fever, chills and Covid/Flu like symptoms; all on 12Jan2021 at 18:00. The events resulted on doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for the events with Sodium Chloride and Dulera Inhaler. The patient did not have COVID prior vaccination, the patient had been tested for COVID post vaccination, which included SARS-CoV-2 (Nasal Swab): negative on 15Jan2021, and Novel Coronovirus PCR (Blood test): negative on 15Jan2021. The outcome of all events was not resolved.
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| 49 | 2021-02-01 | heart rate increased | dizziness, rapid heart beat, shortness of breath, shaky |
| 49 | 2021-02-02 | chest discomfort | Chest tightness and lightheaded |
| 49 | 2021-02-02 | blood pressure increased |
Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to s...
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Patient stated she had tingly of lips, bp was 170/92. Patient checked by medical officer, opted to stay and be observed another 30 minutes. B/p rechecked 163/85. Patient discharged to home at 13:05. Advised to call PCP with any further problems.
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| 49 | 2021-02-02 | fainting |
Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypot...
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Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events due to temporal relationship. However, the events may likely possibly represent concurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-02 | chest discomfort, lightheadedness |
Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath;...
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Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-03 | chest pain |
Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is const...
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Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is constant.
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| 49 | 2021-02-03 | heart flutter, blood pressure increased |
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a...
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Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-03 | chest discomfort |
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. S...
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Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. She was given Benadryl 50 mg IM at 1117
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| 49 | 2021-02-03 | heart rate increased |
Have had intermittent difficulty catching my breath and heart beating fast since administration of t...
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Have had intermittent difficulty catching my breath and heart beating fast since administration of the 2nd vaccine. Symptoms started the day after the vaccine and have continued for 4 days.
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| 49 | 2021-02-03 | palpitations |
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i...
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She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
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| 49 | 2021-02-03 | fainting | Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe |
| 49 | 2021-02-03 | blood pressure increased, heart rate increased |
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf...
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Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
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| 49 | 2021-02-04 | blood pressure fluctuation |
Blood pressure keeps going up and down for couple hours; This is a spontaneous report from a contact...
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Blood pressure keeps going up and down for couple hours; This is a spontaneous report from a contactable nurse (patient herself). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 18Jan2021 at 13:15, at a single dose, for COVID-19 immunization. Relevant medical history included blood pressure abnormal. Concomitant medications included spironolactone. The patient previously received amoxicillin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Nursing Home/Senior Living Facility. On 18Jan2021, at 13:15, the patient's blood pressure keeps going up and down for couple hours. The patient did not receive treatment for the event. Outcome of the event was recovered with sequel. The patient has not been tested for COVID-19 since vaccination. Information on batch/lot number has been requested.
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| 49 | 2021-02-04 | blood pressure increased |
Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in ev...
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Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in evening. 6am on 2/4/2021, slight headache, muscle ache, and dizziness. 11am, increased dizziness. 2pm, tiredness, dizziness, increased muscle pain. (2/4/21) 6pm, tiredness, no appetite, fell asleep in chair. 10pm, awoke chilled and with dizziness and went to bed. Woke from sleep with difficulty breathing/catching a breath (2/5/21) and nauseous. 8am, chills, minor breathing issues, elevated temp (98.1) and headache. Slept upright until 1:30pm.
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| 49 | 2021-02-04 | chest discomfort, chest pain |
discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/whi...
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discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/while the chest discomfort had subsided the burning was back; burning in her lungs; coldness/ all over body coldness; fatigue; chills; This is a spontaneous report from a contactable consumer (patient herself, a medical assistant) via Medical Information team. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration on the right deltoid on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility was the clinic. Vaccine was not administered at a military facility. Relevant medical history included sleeping (problem). Concomitant medications included ongoing trazodone as a sleeping pill and an unspecified multivitamin. The patient had no previous immunizations with a Pfizer vaccine as this was the first dose. She had no prior vaccinations within 4 weeks. The patient was having concerns about the side effects was experiencing after her first dose. The patient received the first dose on 13Jan2021 and afterwards she felt fatigue on 13Jan2021; coldness on 14Jan2021 at 07:30; and chills on an unspecified date in Jan2021. On Tuesday, on 19Jan2021, she started having "burning in her lungs" then the day prior reporting, on 20Jan2021 was a vigorous day at work and she had discomfort in her chest versus (vs) the burning." She stated that at the time of the report (21Jan2021), she was working at home and while the chest discomfort had subsided, the burning was back. The patient was asking if this was normal or expected and she didn't call her doctor; she was asking what should she do. The patient further reported that she did have some common side effects and the some of them were the normal ones such as: fatigue, chills, and feeling cold for a few days. The patient further reported that all over body coldness occurred at 7:30 AM on 14Jan2021; she noticed it shortly after she woke up. She actually noticed it after drinking coffee and then it was like the coldness kicked in. It would get worse as she drank things. It did not matter if it was hot or cold things. It was like the hot things intensified the cold feeling. At the time of the report she was having more concerning symptoms. On Tuesday (19Jan2021), she started to have burning in her lungs and the day prior reporting (20Jan2021) at work, she had chest discomfort. It was a little busy day at work running around on the floor. The chest discomfort was nothing significant, but it was a discomfort, especially on the left side. She confirmed she did not have that discomfort at the time of the report. However, she was having the burning again. She was having concerns and wanted to speak to someone about this. She went on to explain she noticed the fatigue during the night on the day she got the vaccine. It resolved around 16Jan2021. She added she had all over body coldness. She confirmed this was the same as the chills and feeling cold. This feeling comes and goes. She added, it was also winter so it was really hard to tell what it was from. The first two days, she had this chills, cold feeling for two days straight. However, at the time of the report it was better. The chest discomfort started the day prior reporting; however, she was doing a lot of activity and she did not have it today. At the time of the report, she was sitting all day working from home. However, the burning was back. The adverse events did not require any visit to an emergency room or a physician office. She stated she thought about calling the doctor's office, but she had not called them yet. She knew they probably won't be able to help or tell her anything. The patient had no investigation assessment and no relevant test. The patient recovered from the event "fatigue" on 16Jan2021; she was recovering from the events "coldness/ all over body coldness and chills," she was not recovered from the event "burning in her lungs," while the outcome of the events "discomfort in her chest vs the burning/ chest discomfort /while the chest discomfort had subsided the burning was back" was unknown.
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| 49 | 2021-02-05 | heart rate increased |
Left 15 minutes after vaccine. Heart rate increased to 130 and I needed to sit down outside. Heart r...
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Left 15 minutes after vaccine. Heart rate increased to 130 and I needed to sit down outside. Heart rate sustained 120 for about an hour and then dropped to 100 before decreasing back down to a normal baseline. Did not report experience to Kaiser because I didn?t know why my heart rate was so rapid.
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| 49 | 2021-02-05 | very slow heart rate, hypotension |
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese...
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pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
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| 49 | 2021-02-06 | chest pain |
I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, ...
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I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, headache, nauseos and muscle pain where injection is and chest.
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| 49 | 2021-02-06 | hypertension, fast heart rate | tachycardia hypertension itchy tongue and throat |
| 49 | 2021-02-07 | chest pain |
Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Rec...
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Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Received epi-pen, nebulized bronchodilators, steroid injection, diphenhydramine and famotidine. Patient was in ER about 7 hours for observation, improved and was discharged home with supportive care.
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| 49 | 2021-02-07 | chest discomfort | Tightness of cheat and have trouble breathing |
| 49 | 2021-02-08 | hypertension | Systemic: Other- Hypertension 160/100 and started on blood pressure meds |
| 49 | 2021-02-09 | heart rate increased, hypertension |
High heart rate; hypertension; This is a spontaneous report from a contactable pharmacist. A 49-yea...
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High heart rate; hypertension; This is a spontaneous report from a contactable pharmacist. A 49-years-old female no pregnant female patient received ,at hospital, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3249 on 12Jan2021 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes mellitus, ongoing hypertension, high cholesterol. Concomitant medication included metformin (METFORMIN), atorvastatin (ATORVASTATIN), hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). On 13Jan2021 the patient experienced high heart rate and .Lab data included heart rate (13Jan2021): high Outcome of the events was recovering. No Covid prior vaccination, No covid tested post vaccination
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| 49 | 2021-02-09 | excessive bleeding |
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The ras...
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Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.
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| 49 | 2021-02-10 | heart rate increased, palpitations, blood pressure increased |
Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation...
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Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation. I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well. I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
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| 49 | 2021-02-10 | chest pain |
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t...
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Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
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| 49 | 2021-02-14 | blood pressure increased, fast heart rate, palpitations, hypertension, heart rate increased |
Pt had 2nd of Vaccination today and presented with dizziness, anxious and palpitations 10 minutes af...
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Pt had 2nd of Vaccination today and presented with dizziness, anxious and palpitations 10 minutes after the injection. She relates at history of HTN on HCTZ, no cardiac history or diabetes. She works as a Medical Staff and her nurse manager happened to be present and is staying with her. Her initial VS were very tachycardic and hypertensive. 1437 EKG was applied VS 163/114 HR 145 RR 24 sats 100% she does not know her baseline BP. She continues to be lightheaded and dizzy despite sitting in chair and resting with the RN manager. Called Doctor and he recommended to call the RN stat however a code campus was already in process. Second VS at 1449 191/97 HR 145 RR 20 and sats 100% very lightheaded. An IV was placed 22 G to right hand by RN. THe RN stat Team now also at bedside.1500 ER RN with wheelchair to take pt to the ER with RN manager accompaning pt. In ER BED 18 report given to RN same RN who transported pt last VS 174/93 HR 142 RR 18 sats 100%. Having a STAT 12 lead at 1507 in the ED. Doctor informed of pts admit to the ER and sent report and pts MRN to him.
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| 49 | 2021-02-14 | heart rate increased |
Pt stated feeling well more related to anxiety, refused having VS taken. Stated that it will make h...
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Pt stated feeling well more related to anxiety, refused having VS taken. Stated that it will make her feel worse. RR 20, HR 110. Supervisor notified. Pt walked few steps, had water, stated feeling better. Husband called and picked her up/ Spoke with husband and medical team made him aware if pt getting worse need to go to ER
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| 49 | 2021-02-15 | blood pressure increased |
Patient developed sudden dizziness upon leaving the recovery area, and was accompanied by staff to a...
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Patient developed sudden dizziness upon leaving the recovery area, and was accompanied by staff to a laying position on a cot. HR 85, 10:05; BP 154/97, no additional symptoms. 10:10; HR 85, BP 154/97 dizziness improving, no new sx 10:15; HR 84, BP 151/95 dizziness improving, no new sx 10:20; HR 80, BP 134/89 dizziness improved
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| 49 | 2021-02-15 | palpitations |
Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104. Brought in for observation....
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Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104. Brought in for observation. Pt stated being nervous about the vaccine. @1210 HR 80 per Dr. @ 1251 BP 122/70, HR 72, Pt stating feeling better. Dr. walked her to her husband.
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| 49 | 2021-02-18 | palpitations |
approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac...
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approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
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| 49 | 2021-02-18 | heart rate increased, hypertension, palpitations, cardiac arrhythmia |
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of ...
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tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC which is still there. headaches come and go
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| 49 | 2021-02-24 | heart rate increased |
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red...
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12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
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| 49 | 2021-02-24 | chest discomfort |
Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing...
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Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing. Could not clear throat. It felt as if I was put inside a CS chamber. Went to ER. Treated with steroid and antihistamine. Coughing stopped with residual tightness in chest. Tingly stopped and reduced itchiness.
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| 49 | 2021-02-24 | fainting, hypertension |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypert...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Medium
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| 49 | 2021-02-24 | fast heart rate | Tachycardia-HR 122, patient refused transport |
| 49 | 2021-02-25 | heart rate increased |
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate...
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No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
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| 49 | 2021-02-25 | low platelet count, platelet count decreased, fainting |
Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had...
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Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.
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| 49 | 2021-02-26 | fast heart rate, palpitations |
15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted...
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15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted for 5 minutes. The symptoms resolved and then 15 minutes later, the same symptoms occurred and lasted 10 minutes.
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| 49 | 2021-02-26 | blood pressure increased | Throat tingling, flushed, diaphoresis, increased blood pressure to 160's, |
| 49 | 2021-02-27 | chest discomfort |
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no ...
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5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given; 65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
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| 49 | 2021-02-28 | fainting, fast heart rate |
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120...
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Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
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| 49 | 2021-02-28 | fainting |
patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/nec...
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patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/neck. symptoms resolved
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| 49 | 2021-03-01 | heart rate increased, chest discomfort, blood pressure increased |
rapid heartbeat since 2/27 and still on-going, on 2/27 increase blood pressure to 150/100 and is sti...
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rapid heartbeat since 2/27 and still on-going, on 2/27 increase blood pressure to 150/100 and is still elevated since then, on 2/27 shortness of breath and still on-going feel winded if talking for long period of time or walking up stairs, on 2/27 feeling of heaviness in chest and still on-going, on 3/1 experienced dull headache on left temple above eye for 6 hours which subsided after taking Tylenol (2 pills/6 hours)
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| 49 | 2021-03-03 | fast heart rate | Dizzy, anxious, tachycardia, nausea |
| 49 | 2021-03-04 | hypertension |
After receiving the medication, the patient stated that she felt tingling in right arm. She states t...
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After receiving the medication, the patient stated that she felt tingling in right arm. She states that she had a headache. It subsided in 20 minutes. Blood Pressure was very high 5:13PM 175/102 P94 O2 100: 5:19 PM 183/109 P96 O2 100 5:23PM 173/101 P99 O2 100 5:53 PM 162/98 P92 O2 99
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| 49 | 2021-03-04 | chest discomfort |
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa...
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Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
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| 49 | 2021-03-05 | chest pain |
24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms a...
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24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms and legs (bilateral), rash on chest, face, back
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| 49 | 2021-03-06 | chest pain |
pt received vaccine, 15 min later, pt got chest pain & sob, brought back to assessment tent, vitals ...
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pt received vaccine, 15 min later, pt got chest pain & sob, brought back to assessment tent, vitals taken, bp at 208/103, per MD, rec. 911 for tx to ED, pt taken to ED via EMS. BP prior to leaving, down to 158/85, pt still with chest pain, but less painful.
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| 49 | 2021-03-07 | oxygen saturation decreased |
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Foll...
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Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
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| 49 | 2021-03-07 | excessive bleeding |
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a...
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Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
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| 49 | 2021-03-08 | palpitations |
Within one minute of receiving injection, my heart started racing and I felt dizzy and light headed....
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Within one minute of receiving injection, my heart started racing and I felt dizzy and light headed. After waiting at the vaccination site for 30 minutes, my heart rate slowed and the dizziness lifted enough to drive myself home. It's now been almost 3 hours and I still feel a little off but mostly just have a headache.
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| 49 | 2021-03-08 | palpitations |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | chest pain, chest discomfort |
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp...
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Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
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| 49 | 2021-03-10 | palpitations |
I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to be...
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I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to bed, I woke up with my heart racing, intense headache, head spinning, weakness, and sweating.
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| 49 | 2021-03-10 | palpitations, palpitations |
Patient started to feel unwell approx 5 minutes after injection, light headed and dizzy, felt like h...
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Patient started to feel unwell approx 5 minutes after injection, light headed and dizzy, felt like heart was racing. Used our manual BP cuff and check pulse at approx 1:20 was 114/110 P between 98-108. Omrom automated BP cuff to check her at 1:25 BP 138/105 P 103 at 1:28 BP 135/100 P 103. At 1:43 BP 147/99 and P 99 using quick clinic's automated BP machine. Spoke with customer about her normal BP and pulse she states is normally 130/80 and pulse in 80s. She takes metoprolol 50 Er 50 mg bid and said she had not missed any doses recenrly. I asked that she report her bp and pulse to medical provider as they seem elevated.
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| 49 | 2021-03-11 | chest pain |
Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given an...
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Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given and 911 called
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| 49 | 2021-03-11 | heart rate increased |
Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic...
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Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic. I remained there for 90 minutes and the symptoms did not change. Still have splitting headache and some dizzyness here we are two days later . . .
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| 49 | 2021-03-11 | hypertension, chest discomfort | Patient became flushed, chest discomfort, hypertensive |
| 49 | 2021-03-12 | lightheadedness |
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the...
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02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
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| 49 | 2021-03-12 | chest pain |
5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved...
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5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved and itching and paresthesia decreased. bp = 124/64. patient reports resolution of symptoms. Monistored until 5:30pm and allowed to leave.
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| 49 | 2021-03-13 | body temperature decreased |
Approximately 6:55 Friday March 12th I went from feeling perfectly fine to having to lay down I felt...
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Approximately 6:55 Friday March 12th I went from feeling perfectly fine to having to lay down I felt so sick. I took my temperature and it had dropped to 97.6 within a matter of minutes. And then my temperature continued to drop and drop and drop until it reached 96.1. I've never in my life had a temperature that low. I have not had problems with temperature fluctuation like this since I started on thyroid medication. My normal temperature ranges in the 98s.
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| 49 | 2021-03-16 | vaginal haemorrhage |
very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually startin...
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very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.
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| 49 | 2021-03-17 | chest discomfort |
After 7 minutes, the patient developed difficulty breathing, scratchy throat, cough, hives, chest ti...
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After 7 minutes, the patient developed difficulty breathing, scratchy throat, cough, hives, chest tightness, nausea and lightheadedness. She was transferred to the Emergency Department within 5 minutes and was treated with Benadryl, Pepcid, Methylprednisolone, and another medication that she is not able to remember.
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| 49 | 2021-03-18 | chest discomfort, chest pain |
About 10 minutes after receiving vaccine, I experienced a gurgling sensation on the left side of the...
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About 10 minutes after receiving vaccine, I experienced a gurgling sensation on the left side of the chest while breathing. That lasted for about 5 minutes and then dissipated. Throughout the day, I had intermittent chest pain. Upon going to bed that night I found I could not sleep on my right side because it hurt to breathe (primarily to exhale). On my back, I was okay. I had minor chest pain, all on the left side, the next day (3/18) in the morning. By lunchtime it was gone. The evening of 3/18 (roughly 5:15-7:00), I experienced extreme chills. Finally put on my winter coat over my sweatshirt to get warm.
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| 49 | 2021-03-18 | lightheadedness | Vasovagal event |
| 49 | 2021-03-21 | chest pain |
Developed chest pain and right armpit pain 1-day after vaccination. Condition has persisted and now...
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Developed chest pain and right armpit pain 1-day after vaccination. Condition has persisted and now includes indigestion and vertigo.
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| 49 | 2021-03-22 | heart rate increased |
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the ...
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Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?. She described symptoms including itching/tingling, sweating and increased heart rate. She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm. At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM. At this time 25mg of diphenhydramine was given to the patient orally. In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives. EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh. Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
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| 49 | 2021-03-22 | palpitations |
Patient received vaccine around 2:45 pm. At 2:52 pm while in observation area, patient reported feel...
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Patient received vaccine around 2:45 pm. At 2:52 pm while in observation area, patient reported feeling her "heart racing." Patient was seated in a comfortable position and assessed for other symptoms of possible allergic reaction. No other symptoms reported and no signs of anaphylaxis noted (no SOB or rashes, etc). Denied any history of anxiety. At 2:55 pm, BP was 154/84 and HR was 60. Patient was provided emotional support, encouraged to take slow, deep breaths, and asked to stay for monitoring for an additional 15 mins. Patient later disclosed a history of panic attacks and reports being hypertensive during doctor visits. At 3:15 pm, patient's BP/HR were reassessed: BP 146/72/HR 62; patient reported the ?heart racing? sensation had resolved and denied any other symptoms.
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| 49 | 2021-03-23 | pulmonary embolism |
She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 an...
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She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 and diagnosed with bilateral PE's.
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| 49 | 2021-03-24 | blood pressure increased |
3/25/2021 Patient was observed post Covid-19 immunization for 10 minutes as she reused to stay due...
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3/25/2021 Patient was observed post Covid-19 immunization for 10 minutes as she reused to stay due to anxiety . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1148 Alert and oriented, anxiety Actions taken: VS taken at 1148 BP- 181/118, P- 73, O2- 97% Medications administered: No medication administered. Disposition: patient refused further care, concern voiced over elevated BP, and she voiced that it is " usually higher". She refused continued monitoring. She left facility with a friend. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/25/2021 11:38 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 49 | 2021-03-24 | fast heart rate |
she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous r...
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she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-03-25 | heart rate increased |
I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic all...
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I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic allergy history. At 9:21a, while in the waiting area, I felt a flushing sensation through my body and felt my face grow hot. I got very light-headed even though I was sitting down and thought I was going to be sick, and my heart rate as noted on my watch became elevated. It went from low 70's to high 90's. My throat did not close up and I did take my regular allergy medicine and inhalers prior to the vaccine. After 30 minutes, I went to the facility restroom and noted my face was still red. I called my sister (a hospital doctor) who told me to immediately take Benedryl. After taking Benedryl, I was feeling better after about another hour and the nausea and light-headedness subsided. In total, the symptoms lasted about an hour and 45 minutes. I did not notify staff at Med.Centerl at that time as my throat didn't close but did contact my PCP and now have an appointment scheduled with an allergist at Med. Center for next week and have put my 2nd vaccine on hold until I see the allergist.
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| 49 | 2021-03-25 | heart rate increased |
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ...
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On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
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| 49 | 2021-03-25 | hypertension |
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Me...
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: bp 175/110 hr 76 and bp 15 min later 158/100 hr 72 and on bp meds
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| 49 | 2021-03-26 | palpitations, heart rate increased, hypertension, heart flutter |
Within 5 minutes of receiving the vaccine, I noticed my heart racing and fluttering. I asked one emp...
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Within 5 minutes of receiving the vaccine, I noticed my heart racing and fluttering. I asked one employee if this was normal and she replied that it could be anxiety. I waited another few minutes, as it got worse and asked another nurse. She got someone else to come over with a pulse oximeter and she took my blood pressure reading. My heart rate and blood pressure was high. My heart rate and blood pressure are always low normally. They brought me into another area for further onbaervation and kept me for another 45 minutes. By that time, I felt I was feeling well enough to leave with my husband picking me up. Now that I'm home, these effects seem to be coming and going. It is now 4:00 and I'm still having inadvertent fluttering of my heart.
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| 49 | 2021-03-30 | palpitations, nosebleed |
her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn...
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her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn; This is a spontaneous report from a Pfizer-sponsored program. A 49-year-old female patient reported that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), intramuscular in righ arm ton 09Mar2021 (at the age of 49-years-old) at single dose for covid-19 immunisation. The subject had a history of cholesterol (she mentions she takes a cholesterol medication as well but she doesn't have it with her at the time), fibromyalgia, blood pressure and muscle relaxant. Relevant concomitant medications included naproxen for fibromyalgia, lisinopril for blood pressure and methocarbamol for muscle relaxant therapy. The first day after the vaccine, the patient felt nothing, except heartburn. She clarifies further she felt fine the first day, completely fine. The next day, she noticed on her arm, not in the place where they put the vaccine (injection site), but lower down the arm, near her hands, there was a big circle where her vein was. patient may have mentioned the color green, but could not clarify these details further after multiple attempts. She confirmed that 2 days later, this disappeared. The patient also reported that her nose bled as well and felt dizzy and her heart was racing. The reported events were palpitations with unknown outcome, skin discolouration on 10Mar2021 with outcome of recovered, epistaxis on 12Mar2021 with unknown outcome, dizziness on 12Mar2021 with unknown outcome and dyspepsia on 09Mar2021 with unknown outcome.
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| 49 | 2021-03-30 | palpitations |
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; hear...
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severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-04-06 | heart rate irregular, heart rate increased |
heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight...
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heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; This is a spontaneous report from a contactable consumer (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose (at the age of 49-years-old) for covid-19 immunization. The patient had ongoing covid-19 from Nov2020 and has been having post Covid symptoms. The patient also had ongoing heart issues and heart rate issues right now. The patient's concomitant medication included beta blocker (unspecified). It was reported that the patient was calling about the vaccine. She got the first vaccine almost 3 weeks ago and she was due for her second one tomorrow (23Mar2021). She had Covid 3 months ago (reported as Nov2020) and she has been having post Covid symptoms, she have gotten diagnosed with post Covid symptoms. The patient's heart rate goes up and down anyway when she got the first vaccine, about 12 hours after she got it her heart rate ran high for 12 hours straight, that's was the only thing that have ever done that so she was guessing a very usual effect from the vaccine, so she was concerned about getting the second dose. The patient did not received any treatment for the events. The outcome of the events was unknown.
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| 49 | 2021-04-09 | blood clot, heart attack |
Blood clot in LAD which caused a STEMI; Blood clot in LAD which caused a STEMI; This is a spontane...
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Blood clot in LAD which caused a STEMI; Blood clot in LAD which caused a STEMI; This is a spontaneous report received from a contactable consumer (female). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:15 (at the age of 49 years old), single dose for covid-19 immunisation. Medical history included hypothyroidism, Penicillin allergy, both from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The patient experienced blood clot in lad which caused a STEMI on an unspecified date (reported as 03Mar2021 15:15, for clarification since before vaccination date). The outcome of the events was unknown. The events was assessed as serious, causing hospitalization, disability and was life-threatening. Treatment for the events were Balloon in LAD / clot buster. The patient underwent lab tests and procedures which included COVID-19: negative on 03Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-04-11 | heart rate increased, chest discomfort | increased heart rate, chest pressure |
| 49 | 2021-04-16 | fast heart rate |
Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primar...
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Eye bulging, face swelling, tachycardia. ER visit to stabilize, Opthomologist for eye bulge, Primary care doctor for further testing, blood labs, endocrinologist visit and additional labs. Vision care for vision loss.
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| 49 | 2021-04-17 | hypertension |
My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure wa...
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My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-04-18 | transient ischaemic attack |
STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER ...
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STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER AND WAS DIAGNOSED WITH MINI-STROKE WITH POSSIBLE MS ---STILL FEELING WEAK
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| 49 | 2021-04-20 | low platelet count |
microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coag...
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microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co
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| 49 | 2021-04-20 | heart attack, chest pain |
my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; m...
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my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 49 | 2021-04-23 | blood pressure decreased, blood pressure fluctuation |
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98...
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At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown. Information on the batch number has been requested.
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| 49 | 2021-04-24 | fainting |
Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. ...
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Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP7533, via an unspecified route of administration, administered in left arm on 07Apr2021 13:00 as single dose for Covid-19 immunisation. Medical history included Crohn's disease, penicillin allergy. The patient was not pregnant at the time of vaccination. On 09Apr2021, the patient experienced feeling faint and lightheadedness/dizziness. No treatment information was provided. The outcome of the event was not recovered.
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| 49 | 2021-04-24 | loss of consciousness |
Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a c...
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Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 49 | 2021-04-24 | heart attack, blood clot, cerebrovascular accident |
she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weak...
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she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
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| 49 | 2021-04-26 | blood clot |
I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable c...
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I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 03Mar2021 15:45 (Lot Number: EN6202), at the age of 49-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient is not pregnant at the time of vaccination. The patient received dose 1 of the vaccine on 10Feb2021, lot number: EM9810, on 10Feb2021 03:45 PM at right arm. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications were not reported. On 04Mar2021 12:00 AM, patient was diagnosed with a blood clot in her right leg. The event required emergency room visit. The patient was put on Xarelto, a blood thinner for clots. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 49 | 2021-04-27 | loss of consciousness |
This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-o...
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This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-04-28 | fainting, chest discomfort, fast heart rate |
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem...
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This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
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| 49 | 2021-04-28 | fainting |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered. Information about lot/batch number has been requested.
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| 49 | 2021-05-03 | chest discomfort, hypertension, palpitations |
light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure...
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light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-05-07 | deep vein blood clot |
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo...
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2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
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| 49 | 2021-05-07 | nosebleed, fainting |
Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable co...
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Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: ER8737), via an unspecified route of administration, administered in left arm on 05Apr2021 18:45 (at the age of 49-years) as single dose for COVID-19 immunization. Medical history included migraine and known allergies to sunflower oil, chamomile, mold, and dogs. The patient is not pregnant at the time of the vaccination. Concomitant medications included atenolol and rizatriptan benzoate (MAXALT). The patient has no other vaccine in four weeks. The patient previously had allergies to hydroxyethyl methacrylate, sodium pentothal, and erythromycin. The patient was not tested for covid post vaccination. The patient experienced insomnia and headache for three days, and chills on and off for over a week on 05Apr2021 at 21:00. The patient also experienced fainted on 06Apr2021 and nose bleeds lasting 15-45 minutes on 07Apr2021, 14Apr2021, 20Apr2021, and 23Apr2021 (patient never get nose bleeds previously). The patient received pain and antibiotics medications as treatments. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-05-11 | excessive bleeding |
bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg a...
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bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation. The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021. Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order. The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-05-11 | chest pain, ischemic chest pain, heart rate increased |
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h...
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was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-01-01 | chest discomfort |
Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my ...
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Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my primary care office next week Dec 28th, MD confirmed it was swollen lymph node likely related to immune response to COVID vaccine.
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| 50 | 2021-01-03 | palpitations |
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne...
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Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
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| 50 | 2021-01-03 | heart rate increased |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
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| 50 | 2021-01-03 | palpitations | dizziness, palpitations and lightheadedness right after vaccination and lasted up to 2 hours |
| 50 | 2021-01-04 | heart rate increased |
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro...
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8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
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| 50 | 2021-01-04 | palpitations, heart rate increased, chest discomfort |
After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness a...
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After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness and palpitations while in the ER. Given Benadryl and discharged stable. She reported that her heart rate went up again for a few minutes that night at home and next day and then she was fine.
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| 50 | 2021-01-04 | palpitations, blood pressure increased |
BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase flui...
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BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.
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| 50 | 2021-01-04 | heart rate increased |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | blood pressure decreased, heart rate decreased |
diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bi...
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diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
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| 50 | 2021-01-04 | chest pain |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-05 | chest pain |
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began...
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Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
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| 50 | 2021-01-05 | heart rate increased, fast heart rate |
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115...
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Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-05 | chest discomfort, chest pain |
Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trou...
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Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trouble breathing but substernal chest pain 8/10. Vital signs- Temp-97.9 Pulse-95 BP- 162/100 Resp- 22 oxygen saturation- 95 @ room air. 1600- transported to ER for evaluation and treatment.
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| 50 | 2021-01-06 | fast heart rate |
PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, B...
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PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91
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| 50 | 2021-01-06 | lightheadedness |
Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 08...
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Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney 0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same. 0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating "I think I just have to go home and take a nap" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home. 0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN. In ED pt given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv
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| 50 | 2021-01-06 | palpitations |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | chest discomfort |
feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chill...
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feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-06 | chest discomfort, blood pressure increased |
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 an...
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patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
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| 50 | 2021-01-06 | chest discomfort, blood pressure increased |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-07 | chest pain, fibrin d dimer increased |
On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that pe...
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On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that persisted and on January 3rd I was admitted into the hospital. My Ddimer was elevated and my Troponin levels were elevated. An angiogram was performed and Dr. injected nitro into my arteries because they were constricted from Coronary Spasms.
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| 50 | 2021-01-07 | fast heart rate, chest discomfort |
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the...
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Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
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| 50 | 2021-01-07 | chest pain, fast heart rate |
Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids...
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Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
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| 50 | 2021-01-07 | chest discomfort, heart rate increased |
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o...
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approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
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| 50 | 2021-01-07 | lightheadedness | employee felt near syncope[al episode post vaccine administration |
| 50 | 2021-01-07 | pallor |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-08 | palpitations |
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B...
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About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
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| 50 | 2021-01-08 | chest pain |
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. Sh...
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Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range. Â Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.
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| 50 | 2021-01-08 | chest pain | Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills |
| 50 | 2021-01-09 | fainting, hypotension, loss of consciousness |
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start...
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Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
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| 50 | 2021-01-09 | chest pain, chest discomfort |
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,...
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STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
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| 50 | 2021-01-10 | blood glucose increased |
Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 afte...
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Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 after a meal. My diabetes is under control
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| 50 | 2021-01-10 | chest discomfort, hypertension, palpitations |
Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightn...
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Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightness w/ sob, hypertension, and headache - it subsided that night. Had 2 similar episodes since that time. Seen in ED 1/11/21 for symptoms. Similar episode occured after receiving the Flu vaccine about 3 years ago.
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| 50 | 2021-01-10 | chest pain | Right upper chest pain, constant, pain increased with deep breathing, HA |
| 50 | 2021-01-10 | chest discomfort, hypertension |
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness i...
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fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
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| 50 | 2021-01-10 | heart rate increased |
patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient resp...
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patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient response called, patient transported to Emergency Department and received Famotidene 20mg IV, Diphenhydramine 50mg IV, Lorazepam 1mg Oral, Ketoralac 15mg IV, one liter normal saline. Observed and discharged home.
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| 50 | 2021-01-11 | palpitations |
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig...
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30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
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| 50 | 2021-01-11 | haemoglobin decreased |
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; Thi...
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Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-11 | lightheadedness | Received 1st dose vaccine and became nauseated, dizzy, lightheaded and almost passed out. |
| 50 | 2021-01-11 | blood pressure increased, palpitations, heart rate increased |
Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started f...
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Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started feeling like I'm going to have an asthma attack." She reported having headache, chills, her heart racing, "I feel like my airway is closing that I had to cough". Vital signs were taken by staff at the clinic. Patient reported BP was elevated, HR elevated, but O2 Sat was 100%. Within 15 mins symptoms resolved. Patient returned to her work area in the ED that same morning. During her shift she took Motrin for a headache. On 1/8/21, @ 2330 started feeling burning sensation on the injection site, noticed that there was a blister and redness on the area. . 1/11/2021, she reported redness at the injection. All other symptoms resolved on its own.
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| 50 | 2021-01-11 | chest pain |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-11 | chest pain |
Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area when...
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Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area whenever I took a deep breath. No other symptoms. No fever no real shortness of breath only when inhaling deep and exhaling. Continued as a dull ache in the background. I was due for my 2nd covid vaccine which I proceeded to get at 1045am on 1/9/2021. The pain continued as a dull ache in the background. I took Ibuprofen 600mg and then later took a Pepcid 20mg. No real change with the pain and by 3:30pm in the afternoon it was starting to get worse so I when to ER. All tests were normal, I was diagnosed with Pleurisy but no cause was identified. Have taken Aleve 2 x a day for 3 days and tylenol as needed. I self scheduled a covid test 1/11/2021 which was negative. on 1/12/2021 I still have mild pain but it has slowly improved but has not resolved as of this date 1/12/21 Still no other symptoms.
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| 50 | 2021-01-12 | palpitations, blood pressure increased |
My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitati...
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My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-13 | chest discomfort |
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte...
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Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
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| 50 | 2021-01-14 | heart rate increased |
1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point...
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1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point) Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels (down to 92%), Cough 1/14 5:00am - 7:00am Chills 1/14 7:00am - 11:00am Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough 1/14 2:00pm - 3:00pm Chills 1/14 3:00pm - 5:00pm Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough
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| 50 | 2021-01-14 | blood pressure increased |
1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 ...
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1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 88-96%RA; 1345-EE to ED room 14 for further evaluation.
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| 50 | 2021-01-14 | chest pain | 2nd dose- Fever, joint pain, severe neck and chest pain for 36 hours |
| 50 | 2021-01-14 | palpitations |
I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and seve...
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I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and severe body aches, and chills, but no fever. I drank some water and sat up in bed for a while. The pounding heartbeat settled down in about half an hour. I did not take Advil or anything else because of the nausea. Later in the morning I had some nasal congestion. Symptoms persisted but slowly waned until 6:00pm that day. After that, fatigue was the only symptom that lasted until about the 48 hour mark.
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| 50 | 2021-01-14 | blood pressure increased, heart rate increased |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-17 | blood pressure increased | Patient reported shortness of breath and elevated blood pressure |
| 50 | 2021-01-18 | hypertension, blood pressure increased, blood pressure fluctuation |
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj...
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Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
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| 50 | 2021-01-18 | fast heart rate |
Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizzin...
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Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizziness. Next day felt ok but very dizzy. Kept feeling waves of dizziness every 20 minutes or so. Felt feverish that night, but just low grade fever. Also pain in the arm is now in my armpit area, down by my left breast.
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| 50 | 2021-01-18 | hypertension |
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe...
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Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
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| 50 | 2021-01-18 | heart rate increased, heart rate increased | rapid heart rate, fever, diarrhea. called in sick to work. |
| 50 | 2021-01-19 | palpitations | Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site |
| 50 | 2021-01-19 | fast heart rate |
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. ...
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Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. She was observed for 30 minutes and felt better. Symptoms resolving.
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| 50 | 2021-01-20 | palpitations, chest discomfort |
#1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Em...
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#1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Employee contacted company, who in consult with CDC recommended #2 Pfizer 1/14/21 administered at an allergist's office. Instructed to take Claritin 10mg 1hr prior to appt. At 2hrs post vaccine, patient developed similar sxs of chest tightness, DOE, palpitations, O2 sat 87%. Given Albuterol via nebulizer, additional dose of Claritin10mg. Patient felt better 5-10min after neb. D/c'd home after total 3hr observation. Had mild DOE 1/15 that resolved w/in 24hrs. Also severe HA, BA, fatigue, injx site pain. Felt much better on1/16. Denies hx asthma or atopic dermatitis.
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| 50 | 2021-01-20 | cerebrovascular accident |
Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakne...
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Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved
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| 50 | 2021-01-20 | pallor, fast heart rate, lightheadedness, heart rate increased |
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy ...
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She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released. ER records note tachycardia at 107 but otherwise normal VS and exam. .
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| 50 | 2021-01-21 | palpitations, fast heart rate |
I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt...
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I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt very fatigued and fell asleep. At about 11pm I experienced tachycardia that lasted one week with some palpations for another week. My hear rate was over 100. On 12-30-20 my heart rate was not coming down, so i called my nurse cardiologist and he gave me a a refill Metoprolol 6.2mg for me to take this medication only if my heart rate was over 100 to take as needed. I only took Metoprolol for one day. My PCP recommended an EKG. Today I still more fatigued than usual.
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| 50 | 2021-01-21 | fast heart rate |
I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fat...
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I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fatigued and fell asleep. then about 11:30pm i experienced tachycardia which lasted one week. My hear rate was over 100bpm. The next day on 12-30-20, my hear rate was not coming down and i spoke with my cardiologist nurse and she did a refill for Metoprolol 6.2mg. I was to only take it if my hart rate was over 100bpm.
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| 50 | 2021-01-22 | chest pain | Body aches, headache, fever 101-102.2, weakness, shortness of air, severe chest pain |
| 50 | 2021-01-22 | fast heart rate | Fever, chills, tachycardia, muscle aches, vomiting, diarrhea. Lasted 24hours, then resolved. |
| 50 | 2021-01-22 | palpitations |
Within 5 minutes of administration, I experienced increased heart palpitations. To be fair, I exper...
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Within 5 minutes of administration, I experienced increased heart palpitations. To be fair, I experienced random, infrequent heart palpitations before getting this vaccine. When the vaccine was given, I noticed that they were more frequent, and lasted for about an hour, then stopped. Each palpitation only lasted a few seconds.
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| 50 | 2021-01-23 | chest discomfort |
Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experien...
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Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experiencing tightness in my chest and some difficulty breathing, breathing heavily.
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| 50 | 2021-01-24 | chest discomfort, fast heart rate, lightheadedness, hypertension |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-24 | heart rate increased |
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh...
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Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
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| 50 | 2021-01-25 | heart rate increased | Fever, headache, fatigue, increased heart rate |
| 50 | 2021-01-25 | palpitations |
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;...
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Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 50 | 2021-01-25 | body temperature decreased |
muscle aches- back, shoulders, arms chills- Body temp dropped as low as 74 degrees. excessive sweati...
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muscle aches- back, shoulders, arms chills- Body temp dropped as low as 74 degrees. excessive sweating
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| 50 | 2021-01-26 | hypertension |
" Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194...
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" Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194/91. RRT called @ 1510. Pt BP still high 191/100 HR 100. Pt then taken to ED [1518] to be monitored. "
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| 50 | 2021-01-26 | blood pressure increased, fast heart rate |
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard...
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1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
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| 50 | 2021-01-26 | chest discomfort |
BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mi...
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BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mid chest pressure. Not radiating pain and some dizziness. No blurred vision, no nausea. Patient was placed supine and monitored for an elevated blood pressure. first BP was 180/110. HR was 101. Sat at 94% on room air. Had med history of cancer and other conditions. Normal VP baseline is usually low. Vital s taken before 2 EMTs and on-scene doctor. Patient recovered.
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| 50 | 2021-01-26 | chest pain | Chest pain after 15 min discharge approximately 20 min after vaccine. |
| 50 | 2021-01-26 | hypertension, heart rate abnormal |
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl...
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Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
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| 50 | 2021-01-26 | pallor |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | blood pressure increased |
dizziness started 9 days later. Treatment-ER visit and discharged nonspecific. outcome: continues t...
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dizziness started 9 days later. Treatment-ER visit and discharged nonspecific. outcome: continues to work does not interfere with ADL. History of hypertension, BP elevated at ER visit. Dizzy episodes last for 2-3 minutes.
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| 50 | 2021-01-26 | pallor, chest pain |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | hypotension | lightheadness, dizziness, & hypotension |
| 50 | 2021-01-27 | chest pain, pallor |
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o...
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Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
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| 50 | 2021-01-27 | cardiac arrest |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-27 | fast heart rate, blood pressure increased |
Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contacta...
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Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contactable consumer. A 50-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 23Dec2020 11:30 to 23Dec2020 11:30 and from 13Jan2021 13:30 to 13Jan2021 13:30 both intramuscular arm right at SINGLE DOSE for covid-19 immunisation. Medical history included migraine from Feb2015 and ongoing. There were no concomitant medications. The patient stated that she has chronic migraines and takes medications to keep her at a level where she can function. She was on them prior to taking this and did not think they were relevant. She was diagnosed in Feb2015. On 23Dec2020 at 12:00, the patient experienced nausea, blood pressure elevated, tachycardia and vomiting. The patient also stated that she had the same symptoms of events on her second dose. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 50 | 2021-01-27 | palpitations | Patient states her heart was racing and was unable to breath and or swallow. |
| 50 | 2021-01-27 | chest discomfort |
feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issu...
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feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
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| 50 | 2021-01-28 | blood pressure increased |
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star...
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10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
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| 50 | 2021-01-28 | fast heart rate |
28 minutes after accination, SOB mild dizziness with tachycardia. resolved after 15-20 min lying dow...
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28 minutes after accination, SOB mild dizziness with tachycardia. resolved after 15-20 min lying down.
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| 50 | 2021-01-28 | palpitations |
Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report re...
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Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
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| 50 | 2021-01-28 | chest discomfort, loss of consciousness, fainting |
SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the...
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SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the chest. O2 92%, BP 160/ 90, AED no shock advised. EMS arrived and transported to ED
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| 50 | 2021-01-28 | hypertension |
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho...
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Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
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| 50 | 2021-01-28 | heart rate increased |
Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump...
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Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump swelling under arm that I got the shot in. Low grade fever resolved with motrin. Heart remained elevated for almost 48 hours. My resting heart rate is in the upper 50's. It was in the 90's during this time. Lump (swelling) under arm is getting smaller but still noticeably there 3 days later.
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| 50 | 2021-01-28 | hypertension, heart rate increased |
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le...
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pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
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| 50 | 2021-01-29 | hypertension |
This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently r...
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This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently received her second dose of Covid Pfizer vaccine 10 to 15 minutes prior to presentation who presented in ED with complaints of shortness of breath and tingling sensation over her face and neck. Apparently had rash over the first dose and now presented with shortness of breath. She denies any fever chills. No chest pain. EPINEPHrine (EPIPEN) injection syringe 0.3 mg (0.3 mg intramuscular Given 1/26/21 1547) sodium chloride 0.9 % bolus 1,000 mL (1,000 mL intravenous New Bag 1/26/21 1555) dexAMETHasone (DECADRON) vial 6 mg (6 mg intravenous Given 1/26/21 1548) diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg intravenous Given 1/26/21 1548) famotidine (PEPCID) injection 20 mg (20 mg intravenous Given 1/26/21 1548)
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| 50 | 2021-01-30 | loss of consciousness |
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband...
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Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
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| 50 | 2021-02-01 | hypertension, fast heart rate |
Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injec...
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Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injection; lasted 2 hours.
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| 50 | 2021-02-01 | heart rate increased | Elevated heart rate, hives, itching |
| 50 | 2021-02-01 | hypertension |
Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hyperten...
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Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hypertensive
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| 50 | 2021-02-01 | fast heart rate |
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing...
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Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
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| 50 | 2021-02-02 | chest discomfort | Chills that came and went body aches fatigue back pain chest pressure sore throat |
| 50 | 2021-02-02 | heart rate increased | Increased hear rate occurred approx 1 hour after receiving the vaccine, continued for 3-4 days |
| 50 | 2021-02-03 | pallor, fainting |
Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea....
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Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea. Instructed to stay for an additional 15 minutes for extended observation. Approximately 25 minutes after vaccination client feeling faint and described feeling of acid reflux, difficulty recognizing people and disoriented. Also pale, not clammy. assisted to supine position. EMTs onsite and doctor notified. Nausea continued. Vomited x 2. After approximately 60 minutes client was able to sit up. Spouse arrived and accompanied patient out of the building. Patient ambulated with limited assistance by her husband. Husband given recommendations on follow-up, if needed.
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| 50 | 2021-02-03 | blood pressure increased |
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/...
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Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
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| 50 | 2021-02-04 | fast heart rate, fibrin d dimer increased, haemoglobin decreased, heart rate increased |
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient...
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ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
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| 50 | 2021-02-05 | palpitations | Body aches, chills, heart racing, anxiety, fidgety-took Aleve lasted 2 days |
| 50 | 2021-02-05 | chest discomfort | Chest tightness, difficulty breathing, dizziness |
| 50 | 2021-02-07 | heart rate increased, heart rate irregular |
Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient rece...
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Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient received bnt162b2 with concomitant medication prednisone; patient received bnt162b2 with concomitant medication prednisone; Stomach ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 11:00 am at single dose at left arm for COVID-19 immunisation. Medical history included penicillin allergy, nonspecific myositis, small fiber neuropathy, stroke, neurogenic orthostatic hypotension, hypermobile EDS, osteoarthritis, osteoporosis, Raynauds, esophageal dysmotility from an unknown date. Concomitant medications within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA), gabapentin, prednisone (PREDNISON), tramadol. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On same day after vaccination on 21Jan2021, patient had bad stomach ache. Woke up next day shivering uncontrollably, fever of 102 on 22Jan2021 07:45 am. Also heart rate was erratic (patient had dysautonomia) - 140 then dropped to 53 then back up to 123 all in same minute. This happened repeatedly and maintaining high heart rate. Patient didn't receive treatment for events. The adverse events resulted in emergency room/department or urgent care. Outcome of above events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious. Information on the lot/batch number has been requested.
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| 50 | 2021-02-08 | heart rate increased, fast heart rate, palpitations |
hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, g...
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hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, got really hot, heart beat really fast. 1/24-sitting on couch doing nothing, watching TV, chilling. Heart rate was between 106-110. Saw doctor, next day. All was fine. If happens again-do Holter 2/05, and echocardiogram 2/25. Holter-wear monitor for 2 wks. Current sx? just gets episodes-gets really hot, heart beats really fast, palpitations, chills, then ends. This is not all the time. 2/01/2021 ED-SVT. very intermittent, not concerned. do tests that doctor ordered. She has cont to work thru this.
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| 50 | 2021-02-09 | nosebleed |
Nosebleed that would not stop for over 4 hours, went to ED and INR was 9.43. Usual INR is 2.5. Dis...
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Nosebleed that would not stop for over 4 hours, went to ED and INR was 9.43. Usual INR is 2.5. Discontinued Warfarin for 4 days, had INR rechecked on 2/3 it was 1.9.
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| 50 | 2021-02-10 | fast heart rate, lightheadedness, palpitations, cardiac arrhythmia, heart rate irregular |
felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100;...
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felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-14 | chest discomfort |
1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight ...
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1500 Pt informed RN @ 1450, 5 min after injection her tongue went numb. States her chest was tight but she was asthma as well and took her Albuterol which helped. NO chest tightness at this time. Numbness improving.
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| 50 | 2021-02-14 | palpitations |
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain...
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Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-14 | hypertension |
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc...
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She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
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| 50 | 2021-02-19 | chest discomfort | Shortness of breath, chest heaviness immediately after receiving vaccine Dx with bronchospasm |
| 50 | 2021-02-21 | chest pain, chest discomfort |
Patient complained of upper left chest pressure, pain, and shortness of breath when walking back fro...
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Patient complained of upper left chest pressure, pain, and shortness of breath when walking back from bathroom after receiving 2nd dose of vaccine. Patient had been waiting in waiting area and her time was almost up. Patient's vital signs were taken by EMS and bilateral lung sounds were clear and equal. Pulses bilateral radial were normal. Patient was taken by ER in wheelchair. In ED, patient was given IV Benadryl, Solumedrol, Ativan, pepcid, and Normal Saline infusion for acute bronchospasm. Patient improved and was discharged on same day from ER.
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| 50 | 2021-02-22 | hypotension, heart rate increased |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-22 | platelet count decreased, excessive bleeding, low blood platelet count |
Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 ...
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Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.
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| 50 | 2021-02-23 | hypertension |
Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administra...
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Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
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| 50 | 2021-02-23 | blood clot |
blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient ...
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blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 50 | 2021-02-26 | fainting |
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a...
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Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
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| 50 | 2021-02-28 | fast heart rate |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 50 | 2021-02-28 | heart rate increased, hypertension, palpitations |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-03-01 | loss of consciousness, pallor |
almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactab...
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almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
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| 50 | 2021-03-02 | heart rate increased |
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ...
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"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
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| 50 | 2021-03-02 | palpitations |
EXTREME dizziness and nausea. Heart palpitations and chills. And one of the worst headaches of my l...
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EXTREME dizziness and nausea. Heart palpitations and chills. And one of the worst headaches of my life. I called the nurse line and they had me go to the hospital. I received the vaccine on Saturday evening. Symptoms started Monday morning and increased in severity throughout the day until they were unbearable Monday evening.
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| 50 | 2021-03-02 | blood pressure increased, chest discomfort, heart rate increased, palpitations |
Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mil...
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Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mild chest pressure and palpitations. She was brought to the medical tent for evaluation. Her initial blood pressure and heart rate were both mildly elevated (BP 164/97, HR 101). She had an EKG which showed normal sinus rhythm with no ischemic changes. After 10 minutes of observation her symptoms had resolved and her vitals were improved (BP 137/98, HR 86). She was advised that typical chest pain evaluation includes blood tests that can only be done in ER to definitively rule out ACS, and offered transport to ER, but she felt better and declined, stated she would go to ER if symptoms return.
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| 50 | 2021-03-02 | fast heart rate, palpitations |
Pt c/o heart palpitations and lightheadedness. Paramedic assessed pt; HR-188; B/P- 171/105; SpO2- 9...
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Pt c/o heart palpitations and lightheadedness. Paramedic assessed pt; HR-188; B/P- 171/105; SpO2- 99% on RA; completed 4 lead EKG- showed sinus tachycardia. C/O itching and rash noted on chest. Paramedic started 20G IV in R wrist and gave 50 mg of Benadryl. Transported to hospital.
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| 50 | 2021-03-02 | palpitations |
Vaccine was given at 12:45pm. At 3:45pm my heart started racing at 180 bmp and didn't stop till I t...
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Vaccine was given at 12:45pm. At 3:45pm my heart started racing at 180 bmp and didn't stop till I took 80mg of Betapace four hours later. Heart returned to normal rhythm at 9:15pm.
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| 50 | 2021-03-03 | fainting | Scratchy, dizzy, rash, faint |
| 50 | 2021-03-03 | fainting, pallor | funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso |
| 50 | 2021-03-03 | blood pressure fluctuation, oxygen saturation decreased |
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided...
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nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
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| 50 | 2021-03-04 | chest discomfort |
After receiving her vaccine client complained of pressure in her chest. Vital signs obtained by EMS...
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After receiving her vaccine client complained of pressure in her chest. Vital signs obtained by EMS. BP 162/106, HR 82, O2 Sat 99%. Client states she feels better. Client discharged home by EMS.
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| 50 | 2021-03-04 | fast heart rate |
Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I...
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Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I started to cough. It never progressed beyond that. I felt well enough to leave after the 15 min observation period. When I got home, I took 25mg Benadryl.
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| 50 | 2021-03-05 | blood pressure decreased, pallor |
Blood pressure dropped quickly to 89/59 and oxygen level dropped. Felt dizzy like I was going to pas...
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Blood pressure dropped quickly to 89/59 and oxygen level dropped. Felt dizzy like I was going to pass out. Family said I looked pale and yellow in face. Nurses were great but I have never had a reaction to a vaccine before. I don?t think I will get 2nd dose. I will call my family doctor to inform him of what happened. Arm location of shot is red, swollen and tender still today. I have now been feeling ill like flu like symptoms but I was told that is normal.
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| 50 | 2021-03-05 | chest discomfort | Chest tightness, shortness of breath, dry mouth. |
| 50 | 2021-03-05 | chest discomfort |
First felt a surge of heat rising in the middle of her chest, when it dissipated she felt tightness ...
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First felt a surge of heat rising in the middle of her chest, when it dissipated she felt tightness on her chest.
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| 50 | 2021-03-05 | heart rate increased | HA, throat tightness, HR elevated. Cleared by medics |
| 50 | 2021-03-07 | palpitations, hypertension |
10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per ...
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10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per pt, her heart is pounding. RPh checked the blood pressure of the patient, blood pressure reading was 168/60, HR was 77. RPh spoke to another RPh in the store, RPh reported that BP was high for patient and per RPh if we administer EpiPen that can increase the patient's blood pressure even more. RPh gave the patient Benadryl 50 mg. RPh spoke to patient and patient's husband, he recommended to visit the nearest urgent care.
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| 50 | 2021-03-08 | palpitations |
I received my shot and we drove to the parking waiting area. By the time we got to the person to tel...
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I received my shot and we drove to the parking waiting area. By the time we got to the person to tell us where to park I was feeling very light headed. My heart felt like it was racing and I felt like I was going to faint. This was about 2-3 minutes after receiving the shot. The woman told us to park near the EMS tent. We parked and about a minute later I started feeling better. It took about 10 minutes in all to feel completely fine again. I did have a bowl of cereal for breakfast that morning before we left for the appointment, so it wasn't low blood sugar due to an empty stomach. I did call my doctor, but I have not seen him as of yet.
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| 50 | 2021-03-08 | nosebleed |
Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could ...
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Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could not sleep (2:30am) and taking Tylenol only cut the pain 50%. As time progressed that day about 12hours after injection I started to get the chills, achiness even after Tylenol which didn't do much. By 16 hours after injection I got hot/damp, shaky, nausea but once able to cool down nausea resolved. By 18 hours thru 28 hours I had difficulty walking due to achiness and extreme fatigue. Chills going on most of the time throughout and some looser stools. The next day 40h post injection I felt better-no chills. At 48h I was tired- no achiness, some looser stools. Day 3- I had some blood blowing my nose, resolved by day 4.
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| 50 | 2021-03-09 | chest pain, chest discomfort |
Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours...
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Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours post vaccine Chest pain/heaviness which led to some shortness of breath 32 hours post vaccine following temperature returning to normal Treated severe headache with Tylenol without relief
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| 50 | 2021-03-09 | lightheadedness, fainting, loss of consciousness |
Syncope. Vasovagal episode, felt lightheaded. Loss of consciousness < 10 seconds while sitting. Prio...
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Syncope. Vasovagal episode, felt lightheaded. Loss of consciousness < 10 seconds while sitting. Prior history of vasovagal episodes with needles. Vital signs within normal limits.
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| 50 | 2021-03-10 | fainting, very slow heart rate |
SOON AFTER VACCINATION PATIENT EXPERIENCED CHILLS, SYNCOPE AND BRADYCARDIA. EMS ON SITE. PATIENT TRA...
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SOON AFTER VACCINATION PATIENT EXPERIENCED CHILLS, SYNCOPE AND BRADYCARDIA. EMS ON SITE. PATIENT TRANSPORTED TO ER.
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| 50 | 2021-03-11 | chest discomfort |
Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stab...
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Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stable HR 86, Sat 98% RA, BP 107/75. Physical exam were unremarkable and she did not look in any acute distress she just felt anxious. Lungs clear to auscultation bilaterally. She was observed in the car for 30 minutes and was discharged home in stable condition. Denies any symptoms before discharge.
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| 50 | 2021-03-11 | heart rate increased |
Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for a...
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Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for ambulance heart rate 93 heart rate 117 EMS arrived taken to hospital
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| 50 | 2021-03-11 | fainting, hypotension, loss of consciousness |
On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak an...
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On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak and fatigued not able to get out of bed for two hours. I went downstairs to get water, blacked out and completely fainted. I got out of bed around 10:25 or so, went downstairs very slowly, saw clock when I was able to get up around 10:47. I don't believe I was passed out for long. Woke up on kitchen floor, arm bruised. Thankfully head was not injured, apparently fell with arm supporting head (assumption since no head injury). Advised by nurse to come to dr. office, they tested blood pressure, top number was 82 (did the tilt test for orthostatic hypotension). EKG was normal and other blood tests were normal. Was diagnosed with dehydration and low BP. I habitually drink water and even if I did potentially skip a day, I should not faint.
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| 50 | 2021-03-12 | palpitations |
2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to ...
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2/27/21 back of the neck started swelling, intestines gurgling, and a headache. 2/28/21 swelling to entire upper body and severe headache. Right front side a rib pushed out. Slept sitting straight up, could not put pressure on my spine at all. Spouse drove me to the chiropractor on 3/1/21 to have the rib adjusted. Six hours later my heart was literally pounding out of my chest for about a minute. Next day the swelling started to subside and can breathe again. Could lean back on my spine without any issues. Chiropractor on 3/3/21 and will go back next week. Intestines are still gurgling and 3/12/21 experienced diarrhea.
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| 50 | 2021-03-14 | blood pressure increased |
PATIENT WAS GIVEN IMMUNIZATION AND SAID SHE FELT LIGHT HEADED, BUT STATED IT COULD HAVE BEEN BECAUSE...
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PATIENT WAS GIVEN IMMUNIZATION AND SAID SHE FELT LIGHT HEADED, BUT STATED IT COULD HAVE BEEN BECAUSE SHE HAD NOT EATEN. SHE WAS GIVEN A BANANA AND A WATER AND STILL DID NOT IMPROVE. AT THAT TIME SHE MOVED SEATS AND SAID WALKING AROUND HELPED A BIT. WE TOOK BP WHICH WAS SLIGHTLY ELEVATED, PT TOOK BP MEDICATION WHICH SHE HAD NOT YET TAKEN TODAY. SHE STAYED WITH US FOR 45 MINUTES BEING MONITORED, AND A FAMILY MEMBER CAME TO PICK HER UP.
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| 50 | 2021-03-15 | heart rate increased |
15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I...
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15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I got up an started walking I felt slightly unbalanced. 15minutes later I felt like my lips were swelling and my throat felt tight. On route to the emergency room my lips , tongue and mouth felt numb and tingling. I arrived at ER at 0930 and was given IV Benadryl and prednisone by mouth by ER Dr.
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| 50 | 2021-03-15 | chest discomfort |
Thirty minutes after vaccination I went into anaphylactic shock. I kept clearing my throat and my ch...
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Thirty minutes after vaccination I went into anaphylactic shock. I kept clearing my throat and my chest felt really tight. I was really winded and the chest tightness got worse and my throat was closing. I was rushed to the ER and given IV Benadryl and Steroids with Oxygen and I was discharged after 3 hours. I was able to control it for the next few days with Benadryl. I still felt short of breath for the first three days and I still have headaches and since that event. I did not have any previous allergies before this event and had had the first dose of the vaccine.
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| 50 | 2021-03-15 | blood pressure increased, heart rate increased, palpitations |
Two days post vaccination, I developed palpitations, SOB and a headache. By Friday, the duration and...
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Two days post vaccination, I developed palpitations, SOB and a headache. By Friday, the duration and intensity of the palpitations increased. By Saturday, my heart rate and blood pressure were elevated. I was in Bigeminy and developed nausea, dizziness and thightness in my throat. I then spiked a fever of 104I was seen by Cardiology where they performed a battery of tests.
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| 50 | 2021-03-16 | blood glucose increased |
Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated...
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Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated and that her limbs were heavy. She was ambulated with assistance x2 to the exam table by the CNPs. She was laid in the supine position, feet elevated and given a cool cloth for her head. VS 150/96, HR 82 and regular, pulse ox 93% on room air. She was monitored for approximately 10-15 minutes, and the patient then stated that she was having involuntary twitching and her limb heaviness was worse. Strength 3/5 to BUE and BLE at that time. She stated a medical history of anxiety/depression and tardive dyskinesia, NKA, no previous history of vaccine reactions. She states she had eaten breakfast that day but did not have lunch. Her blood glucose was 111. 911 was called to escort the patient to the ER for further evaluation. Vitals remained stable during the observation period, repeat BP 138/76, HR 80 and regular, pulse ox ranged from 89-93% on room air, she did state some heaviness with breathing. Respirations appeared even and non-labored. She remained oriented x4 but was drowsy. She was not able to sit up or move herself to the medic cart upon arrival. Her husband was notified and she was transported to the hospital.
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| 50 | 2021-03-17 | chest discomfort |
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ...
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I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
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| 50 | 2021-03-17 | palpitations |
Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:...
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Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:00 122/86 HR 88 RR20 SpO2 99% 6:00 Benadryl 25 mg given by mouth, patient stated relief after 5 minutes, no SOB, no c/o of chest tightness, no swelling noted prior to medication administration, lungs clear to auscultation.
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| 50 | 2021-03-17 | blood pressure increased |
Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not...
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Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not reactive by speech while on site at facility and blood pressure was 170/110. She was not given an epi-pen but was sent to hospital by transport.
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| 50 | 2021-03-17 | palpitations |
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Ac...
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Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears. Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
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| 50 | 2021-03-17 | chest discomfort |
within 15 minutes or receipt of the vaccine she began to experience " chest tightness" similar to wh...
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within 15 minutes or receipt of the vaccine she began to experience " chest tightness" similar to when she has had bronchospasm in the past. She used her Xopenex inhaler and had resolution of symptoms after 30 minute observation.
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| 50 | 2021-03-18 | heart rate increased |
Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to naus...
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Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to nausea from headache). Warm but did not take temperature.
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| 50 | 2021-03-19 | blood clot, heart rate increased, pulmonary embolism |
10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was eleva...
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10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was elevated. I went to the hospital and they found blood clots in both lungs and I had to be hospitalized.
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| 50 | 2021-03-19 | palpitations, heart rate increased, fast heart rate, chest discomfort |
5 minutes after receiving her first dose of Pfizer COVID19 vaccination, the patient reported feeling...
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5 minutes after receiving her first dose of Pfizer COVID19 vaccination, the patient reported feeling that her heart was pounding. She checked her Fitbit watch and her heart rate was in the 110s-120sh. She also reported having mild chest pressure. Denies any lightheadedness or any other symptoms. She does have a history of anxiety/panic attacks. She reports that her symptoms are similar to previous panic attacks.
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| 50 | 2021-03-19 | fainting, heart rate increased, loss of consciousness |
Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of...
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Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of vaccine given. Tingling started in Left arm tingling own to fingers and traveled to right arm and down through both legs. Rapid heart rate and disorientation prior to fainting. Sternum rub given to revive. Patient vomited. Able to drive home after 30-45 minutes. Continues to feel week and dizzy. Currently 24 hours after incident. Pain in arm preventing me from normal daily activities.
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| 50 | 2021-03-19 | coughing up blood |
Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme t...
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Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum. Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
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| 50 | 2021-03-20 | palpitations, arrhythmia |
c/o palpitations/ irregular racing heart; newly diagnosed arrythmias; HR-78-101; complicated PMH &...
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c/o palpitations/ irregular racing heart; newly diagnosed arrythmias; HR-78-101; complicated PMH & laundry list of daily meds for RA, HTN, lupus; newly dx 2 weeks prior for arrythmias. HR irreg. Radial pulses thready bilaterally. TX mask removed / fresh air - seat reclined; H2O; emotional support - monitored additional 15 mins. advised to pull over & dial 911 if SX worsen. husband drove car off lot.
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| 50 | 2021-03-21 | chest discomfort |
28 hours after my vaccine I had chest pressure for 1 hour, which progressively got worse and lasted ...
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28 hours after my vaccine I had chest pressure for 1 hour, which progressively got worse and lasted in longer increments. The longest of the periods was 20 minutes of constant chest pressure that would not subside not matter how I sat, stood or laid down.
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| 50 | 2021-03-21 | fainting |
Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs...
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Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs. Became very weak. Had to leave the appointment I was at and go home. Became very fatigued and temperature went up to 99.5. All symptoms came out of nowhere. There was no feeling bad or strange before onset.
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| 50 | 2021-03-21 | loss of consciousness |
anxiety before receiving vaccine, received vaccine, felt sick to her stomach, lightheaded, passed ou...
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anxiety before receiving vaccine, received vaccine, felt sick to her stomach, lightheaded, passed out and vomited while unconscious and very diaphoretic
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| 50 | 2021-03-21 | hypotension, loss of consciousness, chest pain |
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor...
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collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
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| 50 | 2021-03-22 | blood pressure increased, palpitations |
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ...
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4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
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| 50 | 2021-03-22 | palpitations |
Client is a 50 y.o. female who received the Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM S...
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Client is a 50 y.o. female who received the Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/23/2021. The patient experienced the following reaction(s) during the immediate of observation: 1023am: pt c/o feeling "dizziness, faint, and palpitations". Patient was treated/managed as follows: 1025am: Pt was seen in treatment area. 1st set of VS are as follows: BP-166/88,HR-64, R-18, 02 sat-97%. Pt offered water for hydration. Pt symptoms began to resolve. Pt states feeling better and not c/o dizziness, faintness, or palpitations any longer. 1035am: 2nd set of VS completed: Bp-142/62, HR-66, R-18, 02-98%. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. 1045am:Pt reports symptoms have subsided. Pt escorted to car by RN.
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| 50 | 2021-03-22 | blood pressure increased |
Patient described feeling her heart in her head with her head pounding about 5 minutes after vaccina...
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Patient described feeling her heart in her head with her head pounding about 5 minutes after vaccination. She was diaphorteic, felt as though she was going to vomit and was dizzy. Her BP was elevated at 186/133 but decreased to 176/87 quickly and came down to WNL after that. BP was also not extremely accurate given patient's arm size and cuff size. RR and O2 levels WNL. Patient was also given diphenhydramine 25 mg. Symptoms resolved within 15 minutes.
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| 50 | 2021-03-22 | chest discomfort, heart rate increased, loss of consciousness |
Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After...
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Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After bringing patient to UC patient felt itching of tongue, feeling like throat is swelling, shortness of breath, dizziness, slurred speech, loss of consciousness, and chest heaviness.
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| 50 | 2021-03-22 | blood pressure increased |
Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to...
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Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to 116/79 over next three minutes with giving juice.
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| 50 | 2021-03-22 | chest discomfort |
Sudden feeling of needing to burp but not being able to, building up pressure. No trouble breathing....
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Sudden feeling of needing to burp but not being able to, building up pressure. No trouble breathing. Just this creepy pressure in the chest. Took tums and then drank herbal tea with honey and it seemed like that helped to get the burps to come through finally so I was able to sleep, but the burping is continuing this morning. Not sure if this is related to the vaccine, but I've never felt anything like this before. I also didn't eat anything outside my norm yesterday and didn't have any alcoholic drinks,
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| 50 | 2021-03-23 | blood glucose increased, heart flutter |
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai...
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Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
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| 50 | 2021-03-23 | palpitations | I have been experiencing heart palpitations |
| 50 | 2021-03-24 | chest discomfort |
Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness,...
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Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness, chest pressure, shortness of breath, extreme tiredness. Everyday passing I was feeling worse, adding radical mood swings. Today March the 25/2021 I am still with taste loss, with chills, with the mood swings (the ones that had me partially hospitalized), the skin pigmentation changes is not the same, and tiredness.
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| 50 | 2021-03-24 | palpitations |
~8 minutes after receiving her vaccine, pt approached pharmacy complaining of racing heart / sweatin...
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~8 minutes after receiving her vaccine, pt approached pharmacy complaining of racing heart / sweating / mild trouble breathing / feeling faint, after assessing pt 1 dose of 0.3 mg epinephrine was administered. paramedics were called to complete a full work up of pt. After checking her vitals and monitoring heart rate, pt opted not to proceed to ER and go home instead.
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| 50 | 2021-03-25 | haemoglobin decreased |
03/24/2021: Patient presented and was admitted through emergency room for CC of melena. stated that ...
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03/24/2021: Patient presented and was admitted through emergency room for CC of melena. stated that she had a BM and had bright red blood at the end. The patient does have a history of peptic ulcer disease and GI bleed. She was admitted last year with GI bleed and was found to have multiple ulcers in the duodenum. Pertinent labs on admission - Initial H&H was 8.9 and 29.6. Repeat H&H 3 hours later?was 7.8 and 24.8. Per the EUA, hospitalizations are to be reported irrespective to attribution to vaccine
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| 50 | 2021-03-25 | heart rate irregular |
I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fa...
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I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fatigue, weak, sneezing, congestion, dripping nose, hot flashes and joint pain. I went to bed and had insomnia the whole night. Had rapid heartbeat and trouble breathing. I called doc next day and they recommended o go to hospital.
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| 50 | 2021-03-25 | chest pain |
Pt states that at 1 am the day after the vaccine she started to feel dizzy, she started with diarrhe...
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Pt states that at 1 am the day after the vaccine she started to feel dizzy, she started with diarrhea and felt ill all day Monday. Monday night when she went to bed she started with chest pain and cough. The chest pain would radiate to her back. Patient had never felt this pain before. she started taking a tea with ginger and lime. The chest pain lasted all day Tuesday and by Wednesday she only had a cough left.
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| 50 | 2021-03-25 | fainting |
Systemic: Vomiting-Medium, Additional Details: patient fainted while in triage...woke up and vomited...
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Systemic: Vomiting-Medium, Additional Details: patient fainted while in triage...woke up and vomited. 911 called, emt's responded. unknown if patient was brought to hospital..
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| 50 | 2021-03-25 | heart rate increased |
at 10:25 Pt stated heart rate elevated- 130, feeling like throat tightening. Pt took own albuterol ...
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at 10:25 Pt stated heart rate elevated- 130, feeling like throat tightening. Pt took own albuterol inhaler. At 10:28 still progressing and she administered her own epipen.. , Hr at 107.Throat felt better. EMS called Transferred to EMS at 10:37. At that time her throat was starting to tighten again.
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| 50 | 2021-03-26 | heart rate increased | Elevated heart rate after receiving vaccine; lessened, but still present days later. |
| 50 | 2021-03-26 | blood pressure increased |
Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she ...
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Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she began to feel nauseous and notified RN gave patient a bottled water. RN assessed patient and notified EMS on scene. During assessment, patient admitted allergies to bee stings (was previously prescribed an Epi-Pen, but has "not had one in a while"). Patient also admitted having recent allergic reaction to seafood 2 months ago that caused lightheadedness and nausea; patient was seen at Hospital for this reaction. Patient also stated an allergy to aspirin that causes "flu-like symptoms." During this assessment, patient appeared to be alert and oriented x 3 with no signs of respiratory distress. During assessment, patient developed red patches on the posterior and bilateral neck, along with red hives (approximately 1/2 inch in size). Patient complained of feeling lightheaded and nauseous. Hands were trembling. Patients vitals were within normal limits, although blood pressure was slightly elevated.
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| 50 | 2021-03-27 | heart rate decreased |
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell....
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For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
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| 50 | 2021-03-27 | chest discomfort |
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod...
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Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
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| 50 | 2021-03-28 | palpitations |
couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib ...
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couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events "swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone" on an unspecified date, while the patient was not recovered from the rest of the events.
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| 50 | 2021-03-28 | hypertension |
shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in...
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shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; got extreme pain all the way down to the tips of my fingers; slight tingling in the fingertips; could not move my arm; nausea; dizziness; bone pain in arms and legs; exhaustion; My arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 50-years-old, administered in Arm Right on 05Mar2021 11:00 (Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included allergies to walnuts. The patient was not pregnant. The patient's concomitant medication included High blood pressure medication. The patient previously took Niacin and experienced allergies. The patient reported, "shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm, starting at the top of my shoulder down to my hand and got extreme pain all the way down to the tips of my fingers with slight tingling in the fingertips. I could not move my arm, blood pressure shot up to 200 then it was 192/121 and so on I was monitored at the hospital for a couple of hours with no change or help. I went home and monitored for 29 hours it stayed elevated in the upper hundreds, spiking lowering down a few to 174/124 and spiking back up I got the vaccine on Friday at 11:00 AM my blood pressure did not break until Saturday around 3:00 p.m. I got other side effects, nausea, dizziness, bone pain in arms and legs, exhaustion but the blood pressure scared me the most. My arm still hurts to this day 12Mar2021. I was evaluated but not given anything to bring it down." The adverse events started on 05Mar2021 11:00 AM. The events resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). No treatment for adverse events were received. The patient underwent lab tests and procedures which included blood pressure measurement: high, up to 200 then it was 192/121 on 05Mar2021 spiking lowering down a few to 174/124 on Mar2021. The patient recovered with lasting effects. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 50 | 2021-03-29 | deep vein blood clot |
Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt). Pt had been more s...
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Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt). Pt had been more sedentary than usual due to winter season. As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15. Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up. Lower extremity dopplers were negative for DVT. Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement. When symptoms progressed, pt presented to hospital on 3/24. 3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction. Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25. Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.
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| 50 | 2021-03-30 | blood clot |
blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; no...
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blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.
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| 50 | 2021-04-01 | loss of consciousness, fainting | dizziness , Fainting, loss of consciousness , shaking ,chills, may be seizure |
| 50 | 2021-04-02 | heart flutter, palpitations |
had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on...
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had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on the inside; Sneezing; chills; feeling feverish; Elbow or right arm muscle was contracting or moving on its own; Heart fluttering; always cold; This is a spontaneous report from a contactable consumer (patient) via the medical information team and a Pfizer-sponsored program, COVAX US Support. This consumer reported similar events for two patients. This is the first of two reports. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Mar2021 11:30 (lot number: EN6204, expiration date: Jun2021) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included lupus from 2012 and ongoing; blood clot disorder from 2017 and ongoing, heart attack from 2010 and ongoing: heart attack/heart condition; stroke in 1992 and ongoing; Sjogren's syndrome from 2012 and ongoing; ongoing allergies to all sulfas, penicillins, latex (no manufacturer lot or expiration date); allergic to dye they put in CAT scans; obese from 2014; gastric bypass from 2014 and pulmonary embolism: rare and grew in her lungs in 2017 and was on apixaban (ELIQUIS) for that now. Concomitant medications included apixaban for pulmonary embolism and blood clotting disorder. The patient had no prior vaccinations within 4 weeks. The patient received a rubella shot and came down with German measles. Family medical history included a large family history of thoracic aortic dissections associated with vascular Ehlers-Danlos syndrome (EDS). The patient experienced heart fluttering on 10Mar2021 at 11:30; elbow or right arm muscle was contracting or moving on its own on 11Mar2021 at 15:00; chills and feeling feverish on 12Mar2021 at 22:30; nose felt like it was burning on the inside and sneezing, on 16Mar2021 at 10:00; achy in 19Mar2021; runny nose, like a muted flu, always cold and had a little heart palpitation in Mar2021. The patient received her first dose on 10Mar2021 and 2 days after she started having chills and feeling feverish. The patient had fever twice. A day before (18Mar2021) she had a slight fever, runny nose and chills. On 19Mar2021, she had chills, achy and felt like she has a fever, but she doesn't have a fever. It was like a muted flu; it was not horrible but can be debilitating at times because she can't function and was always cold. She constantly has chills, then her nose feels like it is burning on inside and she sneezed a few times. She added that 3 days before getting the vaccine (07Mar2021) she was not feeling well and had a rapid COVID test done and it was negative. The day of the actual day of vaccine the patient was okay. The patient has lupus and a blood clotting disorder for which she takes apixaban. She continued that she has not been out of the house since Mar2020. When she got the shot she had a little heart palpitation. She does not know why she was feeling this way after all these days. She wanted to know how long this would last and should she get tested for COVID. There was a lady that was sick when she got vaccinated and they allowed her in. The heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat. It lasted only a couple of hours. She heard that from other people (her sister). No ER or physician's office required. The patient wanted to know how long the side effects were going to continue. The patient wanted to postpone her second dose until after Easter and her birthday, she did not want to be sick during that time. She has re-scheduled her second dose for 05Apr2021. Her son was getting married 27Jun2021 and she saw a study that immunity was still high at 62 days. The patient wanted to know if she would still have immunity or high antibodies on 27Jun2021 or would it still be effective. The outcome of achy, runny nose, like a muted flu, always cold and had a little heart palpitation was unknown. The patient has not recovered from chills and feeling feverish. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312325 Same reporter, same drug and similar event, different patient.
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| 50 | 2021-04-05 | haemoglobin decreased, platelet count decreased, loss of consciousness, fibrin d dimer increased |
Paranoia - yelling at people talking to her on shoulder - gave night meds early - helped Unsteady w...
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Paranoia - yelling at people talking to her on shoulder - gave night meds early - helped Unsteady walking - had sit down then to bed Passed out twice - blood pressure down to 70/40 when paramedics took to hospital - IV fluids
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| 50 | 2021-04-06 | hypertension | after 3-4 hrs bit my tongue, blood pressure escalate extremely high |
| 50 | 2021-04-07 | nosebleed |
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac...
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She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
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| 50 | 2021-04-07 | fainting |
Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestina...
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Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestinal cramping; Low grade fever; Chills; Sweats; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at pharmacy or drug store via an unspecified route of administration, administered in left arm on 19Mar2021, at 50 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included fibromyalgia from an unknown date. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included nifedipine, clonazepam, estradiol and propranolol, all taken for an unspecified indication, start and stop date were not reported. In Mar2021 the patient experienced syncope, assessed as medically significant, vomiting, uncontrollable water diarrhea for almost 12 hours, severe stomachache, intestinal cramping, low grade fever, chills and sweats. No treatment was received for the events. All the events were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 50 | 2021-04-12 | blood clot, cerebrovascular accident | Blood clot, stroke, severe headaches, dizziness, vomiting |
| 50 | 2021-04-12 | cardiac arrest |
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ...
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pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
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| 50 | 2021-04-13 | pulmonary embolism | Pulmonary Embolism (blood clot) |
| 50 | 2021-04-14 | heart attack, cardiac arrest, fibrin d dimer increased |
50 yo female with no medical history known to our system presents with Inferior STEMI with ventricul...
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50 yo female with no medical history known to our system presents with Inferior STEMI with ventricular fibrillation cardiac arrest. Unknown initial downtime without CPR. Arrived by rescue squad and taken emergently to Cardiac Catheterization Lab, required mid-LAD stenting. Therapeutic temperature management (TTM), now rewarmed. Currently intubated on mechanical ventilation, on norepinephrine, poor neurological responses, consider neurology consult for brain evaluation/prognostic recommendations. There is a progress note written by ED RN on 4/12/21 that states family reports she had "her 2nd COVID shot 1 week ago," but per Wisconsin Immunization Registry, only 1 COVID vaccine is recorded.
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| 50 | 2021-04-14 | loss of consciousness |
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho...
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blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
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| 50 | 2021-04-15 | chest pain, hypertension |
Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics eva...
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Within 15-minutes of vaccination, the patient reported headache, nausea, and malaise. Paramedics evaluated the patient on-site. The patient was hypertensive (229/129). EKG demonstrated NSR, rate 85 bpm, no ST elevation. Paramedics transported the patient to Emergency Department. In the ED, the patient developed centralized chest pain, diaphoresis, and right jaw pain, but denies shortness of breath, nausea/vomiting, focal weakness, fever or chills. The patient remained hypertensive (184/85). Physician administered 325mg PO Aspirin, 0.2mg PO Clonidine, and 1 inch topical Nitroglycerin. The labs and imaging did not present evidence of myocardial infarct or intracranial hemorrhage. Due to symptoms on presentation, the patient was admitted to rule out ACS. Upon admission, the patient stated the chest pain "comes and goes", but is not currently having any chest discomfort. Admitting physician administered 5mg PO Amlodipine, 5mg PO Lisinopril, labetalol 10mg IV, and prophylactic Lovenox. As of 4/16, the patient had not been discharged, but their hypertensive urgency and chest pain have resolved and will be treated outpatient. Internist planning patient's discharge.
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| 50 | 2021-04-16 | deep vein blood clot | DVT and PE |
| 50 | 2021-04-16 | fainting |
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi...
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Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
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| 50 | 2021-04-18 | chest pain, pulmonary embolism, deep vein blood clot |
DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pai...
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DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
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| 50 | 2021-04-18 | platelet count decreased |
Manuel factor report number 2021094198 Manufacturing report number 2021093966 Stomach hurt nauseated...
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Manuel factor report number 2021094198 Manufacturing report number 2021093966 Stomach hurt nauseated throwing up dehydrated low platelet count admitted to the hospital.
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| 50 | 2021-04-18 | pulmonary embolism, fibrin d dimer increased, blood clot |
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and sl...
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Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.
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| 50 | 2021-04-20 | heart rate increased |
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus...
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hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-04-21 | chest discomfort, heart rate increased |
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h...
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*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
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| 50 | 2021-04-22 | deep vein blood clot |
Right leg popliteal DVT. Symptoms began approximately 3/28/21 (14 days after receiving vaccine), a...
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Right leg popliteal DVT. Symptoms began approximately 3/28/21 (14 days after receiving vaccine), and patient presented to clinic for diagnosis 4/14/21.
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| 50 | 2021-04-24 | fainting |
Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness...
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Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness; had extreme fatigue; Almost fainted once; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration, administered in right arm on 03Mar2021 19:30 at single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's autoimmune, and known allergies to penicillin. The patient's concomitant medications included liothyronine, and levothyroxine, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was tested for COVID post vaccination. The facility type vaccine was Pharmacy or Drug Store. The patient experienced dizziness on 10Mar2021 at 12:00 and has not ceased. It varies from daily light headedness to extreme dizziness. The patient almost fainted once on an unspecified date in Mar2021. The patient had some degree of dizziness every day. The patient also had extreme fatigue since 09Mar2021. The patient was completely normal and physically active before the first dose, and she have not felt normal since. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab, with both negative test results on 17Mar2021 and on 31Mar2021. No treatment was received for the events. The outcome of the events were not recovered.
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| 50 | 2021-04-24 | lightheadedness |
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out...
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hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
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| 50 | 2021-04-24 | chest discomfort, heart rate increased |
rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous repo...
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rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous report from a contactable consumer (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration in the right arm, on 24Mar2021 15:45, as single dose, for COVID-19 immunisation. Medical history included DCIS stage 0 in left breast in 2017 and known allergies to sulfa based medications. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 26Mar2021, the patient began to experience rapid heart rate and heaviness in her chest. She went to the hospital and was admitted for 1 day on an unspecified date. It was reported that after so many tests (unspecified) in Mar2021, they found nothing. The patient felt light-headed and felt like she needed to catch her breath. Her heartbeat was prominent at times. At the time of the report, the patient was wearing a heart holster for 48 hours. The events resulted to emergency room and physician's office visits. Treatment for the events was reported as unknown. The patient had COVID-19 Nasal Swab in 31Mar2021 and was negative. The outcome of light-headed and need to catch breath was not resolved; and the outcome of rapid heart rate and heaviness in chest was unknown.
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| 50 | 2021-04-25 | cardiac arrest, fainting, pulmonary embolism, chest pain |
On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pa...
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On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pain. She called 911 and they responded to her residence at 0500 a.m. While being assessed, patient collapsed. She was asystolic. CPR was started but to no avail. She was transported to the coroner's office where an autopsy was performed. She had bilateral pulmonary thromboemboli. There were not deep vein thromboses found in her legs.
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| 50 | 2021-04-26 | fainting |
fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nause...
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fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nausea/mild queasiness; dizziness; heat; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slight fever/mild queasiness; slammed my face on the bathroom floor; This is a spontaneous report from a contactable consumer, the patient. This 50 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8733), dose 1 , single dose via an unspecified route of administration in the left arm on 31Mar2021 at 02:30 PM (at the age of 50 years-old) for COVID-19 vaccination. Medical history included Grave's disease under control with medication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desogestrel, ethinylestradiol (KARIVA), methimazole, lansoprazole and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 01Apr2021 at 12: 30 AM, 10 hours after vaccination administration, the patient experienced a sudden wave of severe nausea, dizziness, and heat and fainted. She slammed her face on the bathroom floor and broke her nose (among other cuts & bruises). Afterwards, her only symptoms were fainting injuries, slight fever/mild queasiness for 2 days. The events required a doctor or other healthcare professional office/clinic visit. Laboratory tests included a nose X-ray. Treatment was received for nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises). The clinical outcome of nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 50 | 2021-04-27 | blood clot |
15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report...
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15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report from a contactable consumer (patient herself). This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8732), via an unknown route in the left arm, on 27Mar2021 at 14:45 (at the age of 50-year-old) at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included Factor V Leiden and varicose veins. The patient did not have allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), levothyroxine sodium and Women's multivitamin (unspecified). On 07Apr2021, the patient presented 15 cm blood clot in the left leg-lower calf and superficial vein prominence. The events required a physician office visit. An ultrasound was done but results were not provided. Therapeutic measures taken as result of the events included enoxaparin sodium (LOVENOX) injections for 14 days. Post-vaccination COVID test was not performed. The patient was recovering from the events.
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| 50 | 2021-04-30 | blood clot |
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i...
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A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
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| 50 | 2021-05-03 | fainting |
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do...
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fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
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| 50 | 2021-05-03 | heart attack |
heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across...
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heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer. Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
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| 50 | 2021-05-04 | nosebleed |
Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, an...
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Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
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| 50 | 2021-05-07 | heart rate increased |
Chills; Body aches; Sore injection site; Tiredness; Heartrate high 90s; feeling Unwell; This is a sp...
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Chills; Body aches; Sore injection site; Tiredness; Heartrate high 90s; feeling Unwell; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) via an unspecified route of administration at left arm on 06Feb2021 10:30 (50-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), hypertension, asthma, anxiety, and allergies to honey. Concomitant medications in two weeks included losartan and montelukast sodium (SINGULAIR). There was no other vaccine in four weeks. On 06Feb2021 02:00 (as reported), the patient experienced chills, body aches, sore injection site, tiredness, heartrate high 90s, and feeling unwell. Adverse events did not result in emergency room visit or physician office visit. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included Tylenol 1000 mg. The outcome of the events was not recovered.
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| 50 | 2021-05-12 | inflammation of the heart muscle |
second dose was April 2nd and and her one two weeks earlier; second dose was April 2nd and and her o...
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second dose was April 2nd and and her one two weeks earlier; second dose was April 2nd and and her one two weeks earlier; she has myocarditis; Sick for several days; This is a spontaneous report from a contactable consumer (patient's mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at age of 50 years old as 2nd dose, single for COVID-19 immunization. Medical history included mast cell disease (mast cell activation syndrome). The patient's concomitant medications included other medication: "She received chemo every 2 weeks for it." The patient experienced myocarditis, sick for several days, both on an unspecified date in Apr2021. The second dose was 02Apr2021 and other one two weeks earlier. Description: Reporter stated, the oldest daughter (patient) had, well all of this happen, little last when they got Pfizer Covid 19 vaccine, she got her last one 02Apr2021 and she was sick for several days and they finally diagnosed her at the reporting date, they taken her to emergency room then finally she was able to see a cardiologist, she said that she had myocarditis and they were just wondering, the reporter realized that it could possibly be from the vaccine because reporter just saw that on news and reporter was calling because some information about. When probed if start experiencing the side effect after the second shot: Reporter stated, "Actually she didn't right way." When confirmed about the patient, reporter stated, "She was the only one their whole family got this. Just her." Treatment: She went to the emergency room 2 times and saw cardiologist. No." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 51 | 2020-12-31 | chest pain |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2021-01-03 | oxygen saturation decreased |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-04 | heart rate increased |
chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). ...
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chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
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| 51 | 2021-01-04 | heart rate increased |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-05 | lightheadedness |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-05 | palpitations |
Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes wit...
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Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes within 5 minutes of each other.
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| 51 | 2021-01-05 | palpitations |
Palpitations reported by patient. 35 minutes monitored Vital Signs within normal limits Symptoms re...
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Palpitations reported by patient. 35 minutes monitored Vital Signs within normal limits Symptoms resolved. Released to home.
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| 51 | 2021-01-06 | palpitations |
AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. ...
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AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.
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| 51 | 2021-01-07 | fast heart rate |
Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl an...
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Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330
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| 51 | 2021-01-07 | chest pain, palpitations |
I started few hours later started feeling thought it was stress. The next morning around 9am high mo...
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I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
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| 51 | 2021-01-07 | palpitations |
Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, hea...
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Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, headache, mild muscle aches, chills. After about 2 hours, did not improve therefore was directed to the ED. EKG was normal. CBC, CMP, TFTs all normal. Was monitored for a couple hours and HR improved. At home it took until 17:40 for HR to consistently be 100 or less.. still feel fatigued, headache, and achy.
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| 51 | 2021-01-08 | palpitations |
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ...
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After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
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| 51 | 2021-01-08 | heart rate increased, hypotension, lightheadedness | Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath |
| 51 | 2021-01-08 | fast heart rate | Patient developed tachycardia, vomited and trouble breathing |
| 51 | 2021-01-08 | lightheadedness | c/o dizziness, near-syncope 10 minutes post-vaccination |
| 51 | 2021-01-09 | chest discomfort |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-09 | chest discomfort, hypertension |
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b...
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Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
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| 51 | 2021-01-09 | fast heart rate, blood pressure increased, chest discomfort, hypertension |
Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was tryin...
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Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was trying not to panic. Tachycardia increased to 130s for 2 minutes then came down to 100s, BP 140/86, a little nausea and slight headache. Better at 4:45 thought I was good to leave. Then BP spiked to 180/110s, HR 136, transported to ER for monitoring. Tachycardia and HTN would continue to cycling elevate over next 2hours before being discharged with HR of 100s and BP 150/86
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| 51 | 2021-01-10 | heart rate increased |
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920...
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0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
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| 51 | 2021-01-10 | chest discomfort | Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated |
| 51 | 2021-01-10 | chest pain |
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac...
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Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
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| 51 | 2021-01-11 | chest pain |
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa...
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Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
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| 51 | 2021-01-11 | fast heart rate |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | cerebrovascular accident | on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm |
| 51 | 2021-01-12 | body temperature decreased |
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;...
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Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
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| 51 | 2021-01-12 | chest discomfort |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-13 | chest pain |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-14 | chest pain, palpitations, chest discomfort |
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ...
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Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
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| 51 | 2021-01-14 | hypertension |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-14 | chest pain |
Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This cont...
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Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This continued to get worse on Friday. By Saturday, patient felt she could not get comfortable and was more short of breath. She went to the ER and after multiple tests they found multiple pulmonary emboli. Of note, patient took a long flight on 1/6 and is on hormone replacement therapy.
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| 51 | 2021-01-14 | chest discomfort |
Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my...
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Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my eyes; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 03:45 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021, at 05:00 AM, the patient experienced shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes. Treatment received for the events included an inhaler and acetaminophen (TYLENOL). The outcome of the events shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 51 | 2021-01-14 | very slow heart rate, chest discomfort | body itching, eye itching and irritation, body warm, chest tightness, bradycardia |
| 51 | 2021-01-14 | chest discomfort, very slow heart rate | body itching, eye itching and irritation, body warmth, chest tightness, bradycardia |
| 51 | 2021-01-16 | palpitations |
First dose on 12/18/2020 Second dose on 1/04/2021 Intermittent heart palpitations began early am on...
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First dose on 12/18/2020 Second dose on 1/04/2021 Intermittent heart palpitations began early am on Monday, Jan 11th and occurred again on Tuesday, Jan 12th am (worked nightshift). Again appeared the evening of Wed, Jan 13th. On Thursday, Jan. 14, made appt with my primary MD and appt was at 3 pm the same day. EKG performed at office and was Normal sinus rhythm. BP and HR normal too. MD advised to monitor and call back as needed.
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| 51 | 2021-01-17 | heart rate increased |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-17 | palpitations |
Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection s...
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Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection site and whole injection site arm soreness.
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| 51 | 2021-01-17 | loss of consciousness | On 1/8 I passed out at home, losing consciousness for a few seconds. |
| 51 | 2021-01-18 | heart rate increased |
10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for fu...
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10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for further eveluas
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| 51 | 2021-01-18 | palpitations | Fatigue, wheezing, soreness, palpitations |
| 51 | 2021-01-18 | fainting | vasovagal syncope followed by panic attack |
| 51 | 2021-01-19 | chest discomfort, palpitations |
Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpita...
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Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpitation. In the ED, patient was given IM epi x 1, IV benadryl & solumedrol. Patient states that she felt better. Patient has had a similar allergic rxn in the past to shrimp, beta blockers and lisinopril (cough). Pt has never had to use epinephrine for her allergic reactions in the past. Patient has an epi-pen at home for her son (peanut allergy).
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| 51 | 2021-01-20 | chest discomfort |
Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm ...
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Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm she had mild chest tightness. It persisted for >24. hours. She also had injection site soreness. She was tired for a day. If she talked a lot or got angry, she found it a little difficult to breathe. (Her mother was in the hospital and she had been talking a lot.) She did not have any other symptoms. She reports she was not stressed when she had the vaccine: her mother?s stressful problem started in January. The patient?s symptom severity is rated as: ?mild,? ?not very severe.? If she did not talk, she did not feel anything. The SECOND DOSE was given at my office. The Covid vaccine was administered and the patient was observed for two hours. This was from Pfizer-Biontech Lot EL3246, expiring 4/2021. She had some chest tightness and was given an albuterol nebulizer treatment. Her symptoms resolved and she was discharged to home. I phoned her the next day. She had mild dyspnea the day after the vaccination that resolved that night. She did not have a fever, but did have local soreness, fatigue, body ache, and a headache, for which she took Tylenol. She did see her primary care physician and they discussed the patient?s anxiety due to her mother?s poor health. An EKG will be done.
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| 51 | 2021-01-20 | chest discomfort |
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre...
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feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
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| 51 | 2021-01-21 | body temperature decreased |
"by about 8 hr after I developed chills, low temp, body aches, headache, lasted 24 hours, took tylen...
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"by about 8 hr after I developed chills, low temp, body aches, headache, lasted 24 hours, took tylenol after 4-6 hr."
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| 51 | 2021-01-21 | palpitations |
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Para...
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0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
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| 51 | 2021-01-21 | chest discomfort, hypertension, fast heart rate |
Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hyper...
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Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services (911) were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: The employee was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-21 | heart rate increased, blood pressure increased |
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1...
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Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
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| 51 | 2021-01-21 | blood pressure increased | Throbbing pain R. Clavicle, shaking hands, Flushing, increased B/P |
| 51 | 2021-01-21 | hypertension, fast heart rate, chest discomfort |
received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypert...
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received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-22 | fast heart rate | Chills, muscle aches and weakness, headache, tachycardia |
| 51 | 2021-01-22 | fainting, nosebleed |
I had a syncope on Wednesday night with a nose bleed. I also had bleeding from the back up from my t...
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I had a syncope on Wednesday night with a nose bleed. I also had bleeding from the back up from my throat. My family called 911 and at home the paramedics checked blood sugar, blood pressure and said everything looked ok.
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| 51 | 2021-01-23 | palpitations | Dizziness, headache and mild palpitations lasting for two days. Took Tylenol and stayed in Bed |
| 51 | 2021-01-24 | lightheadedness |
short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do...
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short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.
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| 51 | 2021-01-25 | atrial fibrillation |
Mild myalgias and headache the day after. On Saturday, January 23rd, I had an hour+long episode of ...
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Mild myalgias and headache the day after. On Saturday, January 23rd, I had an hour+long episode of Atrial fibrillation. While I have had other cardiac dysrhythmias throughout my adult life, this is the first time I have had diagnosed Afib. I took one dose of my PRN Propranalol (10mg) orally after a few minutes of the abnormal rhythm. When it didn't convert, I did go to the Emergency Department. My heart converted to normal sinus rhythm while on the monitor but before any other interventions were needed. I have a follow up appointment with my cardiologist tomorrow to determine further care as needed.
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| 51 | 2021-01-25 | hypertension, palpitations, heart rate increased |
about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. ...
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about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
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| 51 | 2021-01-25 | chest discomfort, palpitations, blood pressure increased |
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t...
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warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
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| 51 | 2021-01-26 | heart rate increased, blood pressure increased |
About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had i...
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About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had increased a lot. I just did not feel myself, out of sorts. Paramedics checked my heart rate, pulse ox and BP. O2 was normal - I did not have any respiratory symptoms. My heart rate was quite elevated and blood pressure as well. They had me come to the ambulance to monitor me for a bit longer. Around the injection site I had a large ring of hives, it was red and quite warm. I was red and warm also on my neck and somewhat on the top of my back. They hooked me up to EKG, took my blood pressure, pulse ox and heart rate again, BP and heart rate were still high, O2 sats were normal, but I was feeling better. We waited 15 minutes approximately and they checked my vitals again and my blood pressure has down, as well as my heart rate. So they felt it was OK to discharge me with instructions to take an antihistamine when I got home, and to call emergency services if I needed further help. My symptoms all subsided completely and I was fine at home.
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| 51 | 2021-01-26 | heart rate increased |
Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is rangin...
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Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is ranging from 130s-180s, becoming more elevated with activity. At rest it's varying from 90s to 130s. It is now 1/27/21 at 8:50am and symptoms have continued.
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| 51 | 2021-01-26 | chest discomfort |
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t...
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metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 51 | 2021-01-26 | hypertension |
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu...
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nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
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| 51 | 2021-01-27 | chest discomfort, heart rate irregular, hypertension | Chest tightness and irregular heart rhythm. Elevated blood pressure |
| 51 | 2021-01-28 | heart rate increased |
Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over...
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Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
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| 51 | 2021-01-28 | heart rate increased |
Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reac...
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Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reaction associated with treatment of kidney stones. Allergist believed reaction was related to flomax or oxycodone (neither of these are injectable therapies. Vaccination given. Pt came to staff during the waiting period stating starting just minutes after the vaccination she started feeling of "dry throat." She also noted her heart beat was a little fast. No shortness of breath, no hives or any other signs of reaction. Pt was given diphenhydramine 25 mg orally at 1305. At 1325 Pt reports she is feeling better (she is conversing with friend and laughing). She states she will leave here and f/u with allergist regarding whether or not she should receive 2nd vaccination dose.
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| 51 | 2021-01-28 | heart rate increased |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | lightheadedness, fainting |
patient had a vagal response and partial syncope episode minutes after vaccine was administered. Pat...
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patient had a vagal response and partial syncope episode minutes after vaccine was administered. Patient did not recover so 911 was called and ems arrived to take to the emergency room
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| 51 | 2021-01-29 | fast heart rate |
Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flu...
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Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flushed. Given history of other allergic reactions and rapid onset of symptoms, patient was sent to the ED for additional f/u.
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| 51 | 2021-01-30 | lightheadedness, heart rate increased, blood pressure increased, blood pressure decreased, fast heart rate |
1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. ...
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1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. 2nd dose - tachycardia, onset within a few minutes of injection accompanied by nausea. Had to lie down. Felt fine after a few minutes of lying down. Flushed face. RN thought I was dehydrated, so drank a bottle of water. Had eaten breakfast that day as well as two cups of coffee and some water. Blood pressure elevated lying down and significantly dropped upon standing. After 30 minutes, orthostatic hypotension was gone. About 4 hours later while at home and having already had another meal and lots of water, developed. Orthostatic hypotension again - I simply could not stand for more than 30 seconds without feeling extremely weak and about to pass out. This went away quickly. Then, around 730 at night I stood up to walk across the room and had to collapse into a chair, as I was about to pass out. Again, orthostatic hypotension. No sxs the day following injection.
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| 51 | 2021-01-30 | palpitations | Throat closing, palpitation, lightheadedness, cough with bronchospasm |
| 51 | 2021-01-31 | chest discomfort |
10 days after 1st injection, I started having symptoms. Cough, chest tightness, fever, body aches, ...
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10 days after 1st injection, I started having symptoms. Cough, chest tightness, fever, body aches, chills, etc.12 days after 1st vaccine, I tested Positive for COVID-19.
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| 51 | 2021-01-31 | palpitations |
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f...
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1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
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| 51 | 2021-01-31 | palpitations |
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ...
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malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 51 | 2021-02-01 | fainting |
Dizziness, nausea (Vasovagal). Pts vital signs taken and monitored for 30 minutes. Pts vital signs...
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Dizziness, nausea (Vasovagal). Pts vital signs taken and monitored for 30 minutes. Pts vital signs within normal limits; Pt skin PWD, Pt states she is now symptom free. Pt declines need for further evaluation or transport by medical.
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| 51 | 2021-02-01 | blood pressure increased |
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instruc...
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Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day
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| 51 | 2021-02-02 | hypertension, blood glucose increased, hypotension |
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de...
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**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
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| 51 | 2021-02-02 | chest discomfort | Difficulty swallowing, tightness to neck 30mins after administration |
| 51 | 2021-02-02 | fast heart rate |
I got my dose 2 and all I had was a sore arm in 6 hrs. At the 28 hr mark, I had tachycardia that st...
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I got my dose 2 and all I had was a sore arm in 6 hrs. At the 28 hr mark, I had tachycardia that stayed continuious. It was at 133 when I went to the doctor's office. My arm at the site was hot without brusing and redness. I am currently wearing a Holter Monitor for 2 weeks.
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| 51 | 2021-02-02 | hypertension |
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n...
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On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
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| 51 | 2021-02-03 | palpitations | Heart palpitations during the night of 1/29/2021. Resolved by the next day. |
| 51 | 2021-02-03 | chest discomfort |
Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head...
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Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head . Heavy feeling in chest. Pain around ribs stomach area an hour after shot. Pain in area of shot. Headache and ache in shoulder of arm with shot. Back ache.
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| 51 | 2021-02-03 | chest pain, chest discomfort |
Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps ...
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Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day jan 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan 2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; over all not feeling well; Burning feeling around sternum area; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; 2 hrs after vaccine. Felt like multiples needles like shooting to both side of sternum.; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 51-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 14Jan2021 16:45 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies to medications, food or other products. Historical data includes patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), on 23Dec2020 at 16:00 in left arm for Covid-19 Immunisation. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Jan2021 (2 hrs after vaccine) the patient experienced felt like multiples needles like shooting to both side of sternum. No others symtoms. On the next day 15Jan2021 the patient woke up with flu like symptoms: aches. pain .nausea. tired. little stomach cramps needle like feeling, headache. little dizziness. over all not feeling well. Burning feeling around sternum area. No treatment was given for the events.. However, it was also stated 'Took 2 tylenol symptoms. Remains. I slept off most of the time.'. Clinical outcome of the events Felt like mutiples needles like shooting to both side of sternum, flu like symptoms: Aches. Pain .nausea. Tired. Little Stomach cramps needle like feeling.. Headache. Little dizziness. Over all not feeling well. Burning feeling around sternum area was reported as unknown
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| 51 | 2021-02-03 | chest pain | Severe itching and hives, shortness of breath causing chest pain |
| 51 | 2021-02-03 | atrial fibrillation | Shortness of breath , atrial fib, body aches and fever |
| 51 | 2021-02-03 | chest discomfort, chest pain |
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell...
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This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
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| 51 | 2021-02-03 | body temperature decreased |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-04 | palpitations, chest pain, heart flutter |
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, C...
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FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
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| 51 | 2021-02-04 | fast heart rate |
Pt c/o tachycardia, v/s taken HR = 108 Reg, BP= 110/80 @ L arm. BP checked again after 15 mins 120/8...
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Pt c/o tachycardia, v/s taken HR = 108 Reg, BP= 110/80 @ L arm. BP checked again after 15 mins 120/80. Resolved after 15mins. States relief and d/c in no distress. Advised to notify PCP or go to ED any problems arises. Did not have any recurring or residual effects after tachycardia resolved.
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| 51 | 2021-02-04 | coughing up blood |
Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad en...
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Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.
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| 51 | 2021-02-04 | palpitations, chest pain | pt with sudden onset chest pain and palpitations after event. |
| 51 | 2021-02-07 | heart rate increased |
Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety...
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Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety). Monitored for 60 minutes and drank some water. Started to feel better. Patient said she experienced this after her first dose, but not until after she left the clinic. She said that time it resolved within 12 hours. Patient said she felt well enough to leave and said she'll seek medical help if symptoms don't resolve or worsen.
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| 51 | 2021-02-07 | pallor |
RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask c...
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RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask case name twice, she did not respond, case was began ?snoring? for roughly 3 breaths, then began dry heaving, which produced minute amount of blood tinged phlegm. At this time, case was able to tell me her name and was able to remember that she had just received her vaccine. Per her mother and guardian, case has history of mental disabilities and allergy to oral penicillin. Case also has history of childhood seizures that were so mild, she is not on medication. Case requested to be taken to ED for evaluation.
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| 51 | 2021-02-08 | ischaemic stroke |
1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to ...
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1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.
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| 51 | 2021-02-08 | hypotension |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-09 | palpitations, heart rate increased, hypertension | Systemic: Other- High blood pressure (198/123) pulse (106bpm), palpitation -Medium |
| 51 | 2021-02-10 | palpitations |
nausea, vomiting, dizziness, lightheadedness, headache, feeling of heart palpitations with associate...
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nausea, vomiting, dizziness, lightheadedness, headache, feeling of heart palpitations with associated shortness of breath IV ondansetron, IV bolus normal saline ED visit for > 5 hrs.
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| 51 | 2021-02-14 | anaemia, haemoglobin decreased, platelet count decreased, vaginal haemorrhage |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-14 | blood glucose increased | Pfizer-BioNTech COVID-19 Vaccine |
| 51 | 2021-02-15 | chest pain, fast heart rate |
09:00 PM - every joint in my body hurt that evening. I had to leave work; I couldn't finish my eigh...
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09:00 PM - every joint in my body hurt that evening. I had to leave work; I couldn't finish my eight hours. All my joints hurt - even my toe joints. I called my doctor. I had a fever. That went away in 2-3 days. Two weeks later or so- on February 5, I started feeling pretty bad. I started having chest pains. It progressed. No coughing. By the 10th, I ended up in ER. I thought I was having a heart attack - chest pain I was hospitalized. I am still dealing with that issue. I received morphine I'm diagnosed with Pleurisy -like virus - the lining of chest wall can become inflamed and when I breathe in and out it causes severe pain. Tachycardia - fast heart rate. I'm on anti-inflammatory - Naproxen - 500 mg twice a day and I'm already improving. I saw a cardiac dr today - he says my heart seems fine. I still have a fast heart rate. Pleural Rubbing - he could hear it on my chest wall. I had a positive antibody test - COVID -on January 20th. I'm recovering but I am not recovered.
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| 51 | 2021-02-16 | nosebleed |
Serious nausea Dry heaving for 24 + hours Splitting headache Nose bleed All of this caused severe ...
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Serious nausea Dry heaving for 24 + hours Splitting headache Nose bleed All of this caused severe dehydration. Symptoms started Saturday morning. Doctor had to prescribe Zofran. They did give me the option to go to the ER which I didn?t take. Started the meds on Sunday around 8pm. On Monday morning had to take another dose. After 2 doses and sipping Gatorade the worst of the symptoms receded by 1pm Tuesday but still fatigued 5 days later.
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| 51 | 2021-02-21 | chest discomfort |
Difficulty swallowing within minutes of vaccination. no progression of this symptom and also develo...
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Difficulty swallowing within minutes of vaccination. no progression of this symptom and also developed a mild headache to base of skull. chest feels a little tight. 12.5 mg of Benadryl given about 30 minutes in to observation. After another 50 minutes, headache gone, chest pressure less, and swallowing improved. patient advised to return to ED if symptoms returned or worsened.
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| 51 | 2021-02-21 | nosebleed |
Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night wit...
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Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night with bleeding from right nostril and severe right ear pain
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| 51 | 2021-02-21 | blood pressure increased |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-22 | palpitations | Palpitations 18 hours after vaccine |
| 51 | 2021-02-23 | chest pain |
6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD S...
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6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD SEVERE STOMACH PAIN, CHEST HURT WAS NOT ABLE TO DRAW A DEEP BREATH. RAN A FEVER OF 102.5 OFF AND ON.
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| 51 | 2021-02-23 | blood pressure increased |
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are...
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Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
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| 51 | 2021-02-24 | blood pressure increased |
She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizz...
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She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizzy, and nauseas. She felt "off" to the point of tears. EMS took a look at her and her blood pressure was elevated. When she developed a rash the decided to transport her to the hospital for further evaluation. She was given Benadryl 12.5mg PO before she left the clinic. They started an IV for the patient but did not hook any medications or fluids up at the time.
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| 51 | 2021-02-25 | chest discomfort |
At the vaccine administration location, patient experienced the following symptoms: tightness in che...
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At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
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| 51 | 2021-02-25 | chest pain |
Patient presented to the ED due to shortness of breath and chest pain stating that the symptoms deve...
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Patient presented to the ED due to shortness of breath and chest pain stating that the symptoms developed yesterday after receiving COVID-19 immunization. Patient stated that she has taken multiple albuterol and Benadryl doses yesterday. Pain is located at the center of the chest and bilateral ribs (right more than left). When taking deep breaths the pain increases.
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| 51 | 2021-02-25 | chest pain | stabbing chest pain on left side, occasional belching -- still exists currently |
| 51 | 2021-02-27 | hypertension |
10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to ...
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10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to doctor and he also took blood pressures and still was in the 178-180 range. Never had high blood pressure in my life. Also experienced a broken blood vessel in my eye in between first shot and second shot.
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| 51 | 2021-02-27 | blood glucose increased |
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after...
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Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
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| 51 | 2021-02-28 | heart rate increased |
A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to be...
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A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to bed. Basically slept for the next 36 hours. High fever?Tylenol only brought down slightly and back up within a few hours, severe headache that Tylenol didn?t help, nausea to point of unable to eat or drink because felt like going to puke, dizziness whenever tried to get up, would also get short of breath whenever tried to get up, raised heart rate, fatigue?I was so out of it that my husband had to occasionally wake me to make sure I was still responsive, terrible body aches to the point that it hurt to move.
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| 51 | 2021-02-28 | fainting, palpitations, hypertension |
I experienced bizarre symptoms after my first dose. I had a near syncopal episode, heart palpitation...
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I experienced bizarre symptoms after my first dose. I had a near syncopal episode, heart palpitations, shortness of breath, hypertension and dizziness. I went to the ER due to my symptoms. They performed an EKG, Lab work, X-ray of the chest, Covid test-19 all which were negative. I still have these symptoms which have not gone away.
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| 51 | 2021-02-28 | loss of consciousness, heart attack |
Patient was administered the first dose in the Pfizer COVID vaccine series. During the observation p...
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Patient was administered the first dose in the Pfizer COVID vaccine series. During the observation portion, the patient passed out in the observation area approximately 10 minutes after receiving the dose and became non-responsive with ragged breathing. The pharmacy team responded and administered a dose of epinephrine 0.3mg to the patient immediately and called for EMS who arrived on the scene
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| 51 | 2021-03-01 | heart rate increased, hypertension |
Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue ...
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Elevated heart rate Elevated blood pressure (214/155) Tightening of throat Mild pressure in tongue Treatment- benadryl; close monitoring for 2 hours by nurses and EMS workers
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| 51 | 2021-03-01 | chest discomfort, cardiac arrhythmia, heart flutter |
Symptoms: heavy chest, fluttering, increased awareness of heartbeat,. Symptoms started on Monday Ja...
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Symptoms: heavy chest, fluttering, increased awareness of heartbeat,. Symptoms started on Monday Jan. 25th and continued off and on. Contacted my PCP on 1/27 and 1/28 and went to hospital on 1/28. Diagnosed with PVS and sent home with heart monitor and prescription of Metoprolol Tartrate 25mg twice a day. Followed up with the cardiologist who said that 20% of heartbeats were PVC's in emergency room. Cardiologist ordered echo and have follow-up appointment this month.
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| 51 | 2021-03-01 | heart rate increased |
Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry...
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Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry. I checked my heat rate and it was 160. I motioned for the nurse and the pharmacist who was present monitored me for about an hour. My heart rate did not go below 110 for at least 45 min. I drank water and was allowed to leave once my HR was 88. I was able to drive home and did not have any other symptoms.
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| 51 | 2021-03-01 | blood pressure increased, heart rate increased | treatment - benadryl, hydration, rest, monitoring vitals at home |
| 51 | 2021-03-02 | chest pain, fast heart rate, pulmonary embolism, fibrin d dimer increased |
51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unab...
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51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath; day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel, a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.
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| 51 | 2021-03-03 | pulse abnormal, pallor, fainting | Pulse weak. Thready, Lips pale, Fainted. Refused transport. Evaluated by EMS-Cleared |
| 51 | 2021-03-03 | blood pressure increased, chest discomfort, palpitations, chest pain |
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),...
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half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
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| 51 | 2021-03-04 | hypertension, chest pain | Sore arm, temp 99.9, headache, fatigue, dizzy, HTN, sweats, chest pain |
| 51 | 2021-03-05 | chest discomfort |
11:17am Tightness around chest, as if bra band was suddenly two sizes too small, but no problem brea...
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11:17am Tightness around chest, as if bra band was suddenly two sizes too small, but no problem breathing. Lasted five minutes. 11:20am Slight tightness in throat. Lasted five minutes. 5:00pm Injection site pain, intermittent for two weeks.
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| 51 | 2021-03-05 | palpitations |
On 3/4/2021 I felt heart racing and use the pulse oximeter which show heart rate 140-150 and saturat...
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On 3/4/2021 I felt heart racing and use the pulse oximeter which show heart rate 140-150 and saturation 94%. I called my doctor office and was told to go to the hospital.
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| 51 | 2021-03-05 | loss of consciousness |
Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and...
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Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and was not responsive for about a minute. After that time, the patient came back to consciousness and was able to articulate her symptoms, She felt warm for a few minutes and was brought an ice pack to cool down.
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| 51 | 2021-03-06 | chest discomfort, palpitations |
Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very ...
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Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very light headed and my face was flushed. It took about 10 minutes of trying to force myself from panicking ( I do not get panic attacks). There were too many other people in the waiting room so I didn't feel like I could discretely tell the nurse about my reaction. I felt light headed the rest of the day. About 5 days later, I was sitting in the chair at my salon and it happened again. Racing heart rate and all the same cardiac symptoms as before. I do not have high blood pressure or any cardiac illness. I also had a heaviness, congested feeling in my chest for about 2 weeks. I had another issue with very rapid heart rate for most of the day over the last two days.
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| 51 | 2021-03-07 | fainting |
I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I wok...
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I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I woke up at 1:15 a.m., felt okay, walked to the bathroom, and suddenly felt extremely nauseous and thought I might vomit. After walking a few steps, I fainted unexpectedly and got a concussion from the fall. Note: I had hit my head earlier that day on something while standing up, but that had not caused any symptoms.
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| 51 | 2021-03-07 | palpitations, blood pressure increased | rash over entire body, heart palpitations, increased blood pressure |
| 51 | 2021-03-10 | chest discomfort |
Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shor...
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Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shortness of breath, and chest tightness. Pt was given benadryl and EpiPen at approx. 0930. Pt was referred to Hospital ER where she is presently being monitored.
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| 51 | 2021-03-10 | fast heart rate | Tachycardia |
| 51 | 2021-03-10 | chest discomfort |
chest tightness, throat tightness, itching, headache, and nausea, which are consistent with her usua...
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chest tightness, throat tightness, itching, headache, and nausea, which are consistent with her usual anaphylaxis symptoms with first COVID-19 mRNA vaccine IM. Called RRT. Taken to ED. Took diphenhydramine 50 mg PO. Patient had an EpiPen, but wanted to wait to see if diphenhydramine worked. Symptoms improved over 20 minutes. Observed patient until fully resolved. Instructed patient to return to ED if symptoms worsened or returned.
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| 51 | 2021-03-11 | hypertension |
Allergy - itch in ears ., face back throat felt a bit tight on one side swollen a bit and nose insi...
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Allergy - itch in ears ., face back throat felt a bit tight on one side swollen a bit and nose inside felt swollen took a Benadryl there blood pressure was high
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| 51 | 2021-03-12 | heart rate increased | Elevated HR, Flushing. Evaluated by EMS-Cleared |
| 51 | 2021-03-12 | hypotension |
PT FELT WARM ,HER BLOOD PRESSURE WAS LOW .GAVE PT ICE PACK AND ELEVATED FLEET. PT ALSO FELT LIGHTHEA...
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PT FELT WARM ,HER BLOOD PRESSURE WAS LOW .GAVE PT ICE PACK AND ELEVATED FLEET. PT ALSO FELT LIGHTHEADEDED
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| 51 | 2021-03-12 | blood pressure increased |
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ...
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Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
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| 51 | 2021-03-13 | chest pain |
Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was ...
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Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was sitting in the waiting area for the mandatory waiting period of 15 or so minutes - I felt a slight pain in my left arm, a slight pain in my left chest area, and a slight pain in my left back area. I came home and felt a brain fog. I was forgetful, and very slow, I could feel a part of me being acutely aware that I was struggling to process information that I processed before normally. I was very irritable more so than I have experienced before, and that lasted approximately days till March 17th. The brain fog dissipated slowly over 24 hrs, Blood Pressure on March 11th ( fourth day) was 143/80 - 69 beats per minute at 6:15 pm and 155/88 - 75 BPM at 8:14 pm. Blood pressure reading on March 12th 155/105 - 71 bpm at 5:31 pm. and 142/98 - 80 BPM at noon . The pain in the chest and arm area existed, for a few more days and is intermittent in the last few days. Today 3/13/21 i felt it when i was bending to push and pushing potted plants around. But that was the only time. Today's BP reading was 139/85 - 88 BPM at 6:15 pm. I am concerned if I should take the second dose or not. If this is normal and Im ok to take the second dose please email me either way. I just want to ensure that this is not an adverse cardiological side effect and wanted to check in . Thankyou
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| 51 | 2021-03-14 | heart rate increased, blood pressure increased | Shortness of breath Rapid heartbeat Elevated blood pressure Dizziness Felt faint |
| 51 | 2021-03-15 | palpitations |
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5...
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Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
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| 51 | 2021-03-15 | chest pain |
Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to den...
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Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to dental chair, Dr called and vitals taken at 16:30 was O2 92%, BP 142/91. 16:38 pt complains of slightly improved CP and but tingling in both arms and hands, O2 remains 92-98%. EMS called at 16:40. Aspirin 325mg chewed given 16:50. Pt declined ambulance ride to ER but agrees to go to ER with daughter immediately for further assessment.
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| 51 | 2021-03-16 | heart rate irregular, chest discomfort | Persistent chest tightness and irregular heart rate; transported to ED |
| 51 | 2021-03-16 | heart rate increased, chest discomfort |
The following is the timeline of progression: First 48 hours: Immediately following the vaccine I fe...
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The following is the timeline of progression: First 48 hours: Immediately following the vaccine I felt I would vomit. That lasted 2 hours. The remainder of the 48 hours I had a growing headache that turned into a migraine level. Cognitively my husband would say I was out of it, not able to focus. The area around my eyes – my eyelids and below eyelids bright red – like I had put a bright red blush on them. Three to four days later: Saturday night my symptoms started to progress over a span of a few hours very drastically. I had symptoms of Diarrhea– crazy impact in my gut. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. By Sunday afternoon I had full blown symptoms of stomach flu. I had chills, extreme nausea that became debilitating. We do not have a thermometer that works, as a result I do not know if I had a fever. By Sunday night I was vomiting and symptoms progressed to tightness of chest, shortness of breath, vomiting, diarrhea, chills. My gut was literally moving in sharp pain, sounds, and cramping. It was severe diarrhea. I was achy and tired, but could not fall asleep due to nausea and vomiting. I was unable to stand up without the fear of passing out. I tried to manage the nausea with medicine that I have at home. It assisted but did not ultimate make an impact. By 4:30 a.m. I was scared by the lack of breath and asked my husband to call 911. The paramedic stated that I had an increased heart rate, but good blood pressure. I went to the hospital and received fluids, two different additional doses of nausea medicine, oxygen and a gut muscle relaxer. After 30 to 40 minutes I showed improvement and was able to go home. Still had pink color tone in skin around my eyes. On that Monday (2/8/2021), I was unable to go to work and called in for Covid PTO. I slept most of the day. Five days later: Still have a headache that can be managed with Tylenol. I still have diarrhea. I no longer have nausea, the pink color around my eyes seems to be gone.The nurse team and ambulance team all stated that the second shot was awful. Three folks stated they were in fetal position for two days. I was not able to ask what that meant due to my extreme nausea and trying to not dry heave. Note: I did not have any symptoms from the first vaccine – just a dull headache.
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| 51 | 2021-03-16 | palpitations |
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6...
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Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
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| 51 | 2021-03-17 | palpitations |
Patient complained of palpitations & itching to her face & scalp at 1:33pm post pfizer second dose v...
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Patient complained of palpitations & itching to her face & scalp at 1:33pm post pfizer second dose vaccine. BP=168/85, P-93, SPO2-99%, RR-24 at 1:33pm. No complaints of shortness of breath. No hives or swelling noted. Patient self medicated with Benadryl 50mg PO at 1:35pm. Assisted patient to the nurse's station. BP=149/79, PULSE-83, RR-22, SPO2-99% at 1:57pm. Patient observed for an hour and left with no distress noted. She stated "I feel better" at 2:15pm. Doctor informed & cleared patient.
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| 51 | 2021-03-17 | hypertension |
when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high ab...
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when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high about 15 mins after, my right side of face and arm went numb, that went away but that night I had body aches headache fever chills and fatigued which was out of the ordinary for me. About two weeks later I tested positive for Covid. I'm still dealing with covid related symptoms but I don't think that was from the vaccine
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| 51 | 2021-03-18 | palpitations |
2 weeks after my second vaccine I had a bad panic attack. I have never had one before. I have had m...
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2 weeks after my second vaccine I had a bad panic attack. I have never had one before. I have had mild anxiety in the past but nothing like this. I continue to have major anxiety with a rapid heartbeat at times. I feel my body is experiencing something it has never before. Due to my multiple medical issues I am very aware of changes in my body and this ongoing severe nervousness and anxiety is definitely new. My husband and my family see a change in me as well.
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| 51 | 2021-03-18 | heart rate increased, pallor, blood glucose increased |
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu...
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Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
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| 51 | 2021-03-18 | blood pressure increased |
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva...
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Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
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| 51 | 2021-03-20 | fainting, hypotension, pallor |
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control...
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The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
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| 51 | 2021-03-21 | chest discomfort |
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then...
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Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
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| 51 | 2021-03-21 | palpitations, chest discomfort |
chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke ...
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chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes/patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150; This is a spontaneous report from a contactable Nurse (patient herself). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E16198), via an unspecified route of administration, administered at Right arm on 02Mar2021 15:00 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included: Diabetes, hypertension, asthma, vitamin D deficiency, known allergies: Serevent inhaler. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included lisinopril, cefixime (FLEXERIL), colecalciferol (VITAMIN D). On 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes. Then at 15:00, the patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150, chest was a little tight and short of breath. No chest pain. Patient went to hospital. The patient was hospitalized in Mar2021 for all events. Patient still get heart racing on and off. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for all events. The outcome of the events was Not recovered.; Sender's Comments: Pending the investigational results and clinical diagnosis, the company does not attribute the events palpitation, chest tight and short of breath to BNT162B2. The underlying hypertension, diabetes and asthma are considered as risk factors for developing the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-03-21 | deep vein blood clot |
left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consum...
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left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264, unknown expiration), via an unspecified route of administration in left arm on 18Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and Leiden factor 5. Concomitant medications included etanercept (ENBREL); gabapentin; meloxicam; and vitamin D3. The patient previously took Keflex and experienced allergies. The patient also received first dose of BNT162B2 (Lot number: GL9261, unknown expiration) in left arm on 28Jan2021 at 01:00PM for COVID-19 immunization. On the night of second dose on 18Feb2021 at 08:00 PM (20:00), the patient experienced left calf pain. Then quad pain started 2 weeks later along with the return of calf pain. The patient was diagnosed on 15Mar2021 with a significant DVT in left quad. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The event significant DVT in left quad resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient is currently on blood thinners as treatment. The patient is recovering from the event. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-03-21 | chest pain | shortness of breath, cough and intermittent chest pain |
| 51 | 2021-03-22 | palpitations, heart rate increased, blood pressure increased |
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo...
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Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
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| 51 | 2021-03-22 | chest discomfort, pulmonary embolism |
Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/2...
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Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21
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| 51 | 2021-03-22 | fast heart rate |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (speci...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Tachycardia-Medium
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| 51 | 2021-03-22 | palpitations, chest discomfort |
Vaccine time- 1335 S/S onset- 1345 51/F reports SOB, chest tightness and heart racing 10 mins after ...
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Vaccine time- 1335 S/S onset- 1345 51/F reports SOB, chest tightness and heart racing 10 mins after vaccination. She states it feels like a panic attack. Pt AOx4, Tachypnea, Shallow respirations, speaks in short sentences but able to follow commands. Lungs CTA, heart sounds wnl. Instructed to bring mask down and take deep slow breaths. BP-140/100, Hr-76, O2-99%, RR-22. 1400- 122/90, Hr-70, O2-97%, RR-18. Denies any symptoms at this time. Lungs CTA, speaks in clear complete sentences. No chest pain. 1415- BP-119/90, HR-72, O2- 96%, RR-16. Pt AOx4, resp even, skin wnl, lungs CTA, ambulates with an even gait, denies any symptoms, chest tightness and SOB have subsided. RN
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| 51 | 2021-03-22 | palpitations |
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a ...
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Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been taking Benadryl every 4 hours.
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| 51 | 2021-03-23 | chest discomfort |
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger ...
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I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
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| 51 | 2021-03-23 | heart rate increased, blood pressure increased | Pt felt faint, increase blood pressure and increase pulse rate |
| 51 | 2021-03-24 | heart rate increased |
Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use res...
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Difficulty breathing - asthma attack was induced 45 minutes later after injection and had to use rescue inhaler 2X; Tingling sensation of tongue w/i 10 min of injection; Lips felt puffy w/i 10 min of injection; Increased heartbeat - RN measured it at 95 BPM after injection w/i 10 min of injection - normally it is at 66 BPM resting; Bad rash on left arm around injection site after returned home 1 hour later - took orally one Benadryl tablet 25mg Dizziness w/i 15 min of injection - had to lay down at hospital; Felt sick to stomach w/i 15 min of injection - had to lay down at hospital
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| 51 | 2021-03-24 | chest discomfort, chest pain, fast heart rate | Tachycardia, chest tightness, chest pain |
| 51 | 2021-03-24 | heart rate increased | Tingling tongue, fullness in back of throat, difficulty swallowing, rapid heart rate |
| 51 | 2021-03-25 | blood pressure increased |
At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately ...
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At 1405, patient began c/o headache with a 9/10 pain level. Patient had been waiting approximately 30 minutes post-vaccination due to previous reaction to flu vaccine. Vital signs were taken by MSN RN and EMT at 1405 with BP of 179/98, HR 72 and O2 Sat of 95%. Patient also stated that "her throat felt like something was stuck in it like indigestion". Patient also states that she took 1000 mg of Tylenol at 1200 with food prior to vaccination. At approximately 1430, a second set of vital signs were taken with BP 179/89, HR 73, and O2 sat of 95%. Patient was offered and accepted ambulance for further evaluation. Due to increased BP and HA, patient was then transported to Regional Hospital for further evaluation.
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| 51 | 2021-03-25 | blood pressure increased |
Client felt nauseated, dizzy and lightheaded after vaccination at the table vaccination site. MD on ...
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Client felt nauseated, dizzy and lightheaded after vaccination at the table vaccination site. MD on site was called who evaluated client. She was given water and crackers and was monitored for 30 minutes. Was stable then drove home.
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| 51 | 2021-03-25 | hypertension | Nausea, hyperemesis, chills, hypertension |
| 51 | 2021-03-25 | cardiac arrhythmia, chest pain |
VR recipient with history of SVT/PVC's, anxiety and cardiac ablasion felt symptoms of lower chest pa...
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VR recipient with history of SVT/PVC's, anxiety and cardiac ablasion felt symptoms of lower chest pain and PVC's approx. 5 min after vaccination; a somewhat normal feeling for her. EMS was called
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| 51 | 2021-03-25 | heart rate increased |
tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from sh...
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tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from shoulders down to fingertips that happened simultaneously (one occurence), slight swelling and tingling sensation of lips.
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| 51 | 2021-03-26 | chest pain |
developed chest pain with numbness radiating down left arm. Paramedics called, patient refused trans...
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developed chest pain with numbness radiating down left arm. Paramedics called, patient refused transportation to ED for evaluation. Patient instructed to seek care if symptoms continue or get worse. Patient verbalized understanding of all information.
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| 51 | 2021-03-27 | blood pressure increased |
Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Pa...
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Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Patient was removed from cell and brought to the medical observation area. Her BP was 128/82, P 62 RR 16 @ 3:25 she was alert and oriented times 3 ,at 3:38 her blood pressure was 141/94 and at 3:45 was 148/91 HR 68 at , O2 sat 100%. Her tremors began in her right hand and then went to her trunk and legs. She began to hyperventilate, patient was warm to the touch and an ice pack was provided to her She was not able to have a mask in place and she was hyperventilating, we asked her to focus and take deep breaths she was responsive to that and stated that helped to calm her down. Her husband was brought to her side, her vital signs continued to be obtained. at 3:50 her bP was 156/99, HR 104, pulse ox 99, at 3:55 BP was 150/102 HR 106. EMS was called as patient continued with tremors and her blood pressure continued to be elevated . EMS arrived , her final blood pressure was 156/99, HR 90 and pulse ox was 99%. EMS transported patient out of the center via stretcher. Patients husband planned to follow her to the hospital
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| 51 | 2021-03-28 | chest pain |
Received 1st dose Pfizer vaccine 2/24 and reports sx (SOB/Chest pain) started after getting vaccin...
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Received 1st dose Pfizer vaccine 2/24 and reports sx (SOB/Chest pain) started after getting vaccine. Also reports a dose of benadryl helpful. Veritor neg, PCR negative. Tetanus vaccine listed under allergy/advReactions with "unknown" reaction. Discharged from ED same day.
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| 51 | 2021-03-28 | chest discomfort |
autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fati...
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autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EN6199) injected intramuscularly in left shoulder (left arm) on 09Mar2021 13:30 at age of 51 years old at single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Ehlers-Danlos syndrome (EDS), neurosarcoidosis (diagnosied 1997 with remission since 2002), high cholesterol, depression, gastrooesophageal reflux disease (GERD), osteoarthritis. Allergies to penicillin (no specific manufacturer, lot or expiration) in 1990. Obesity through all her life. No relevant test. Diagnosed allergies, compromised immune status, respiratory illness. There was no family medical history. Patient was not pregnant. There were no additional vaccines administered on same date of the Pfizer Suspect. There were other medications in two weeks. There was not covid prior vaccination. There was no other vaccine in four weeks prior vaccinations. The adverse event patient experienced: lose of voice with shortness of breath with communication and chest tightening, fatigue. This similar to her neurosarcoidosis diagnosied 1997 with remission since 2002. The events started on 10Mar2021 11:30 AM. Received call from consumer regarding the Pfizer COVID vaccine 1st dose. She was losing her voice. She was a pediatric Occupational Therapist. She was eligible on Tuesday for the first dose and went and got it. Her main concern was the symptoms she was having was the same thing that comes out when her autoimmune was exacerbated. She would like to know if it was safe to get next dose. When providing her weight, she said she was not a small girl. There was no prescriber. She was waiting to see if it would disappear before calling Pfizer to report it and it did not. It started yesterday about 24 hours after the vaccine. She received it for prevention and for the population she works with. A lot of her kids she worked with were autoimmune compromised. The majority of her medications she had been on for over two years, so she did not feel they were relevant. No further details provided. No Emergency Room (ER) or physician's office required. She called her physicians' office and they suggested she contact Pfizer. Patient received covid tested post vaccination: nasal Swab/Antigen on 09Feb2021: negative. Outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-03-28 | blood clot |
heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lo...
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heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lots of blood clots; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer product), lot no. EN5318, via an unspecified route of administration (left arm) on 19Feb2021 at a single dose for COVID-19 immunisation at a workplace clinic. Medical history included high cholesterol and anxiety. No known allergies. No COVID prior to vaccination. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (brand: Pfizer, lot no. EL9261, left arm) for COVID-19 immunisation on 30Jan2021 at age of 50 years old. No other vaccine in four weeks. The patient was experiencing extended and heavy menstrual period. Her cycle began on 05Mar2021 and was still happening as of today 16Mar2021. She had heavy bleeding with lots of blood clots. This was not normal for her at all. She is calling her doctor tomorrow. No treatment received for the events. No COVID test post vaccination. The outcome of the events was not recovered.
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| 51 | 2021-03-30 | chest pain |
blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-co...
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blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included obesity and inactivity. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood clot in her lungs and was hospitalized on 14Mar2021. Patient also experienced shortness of breath and chest pain on an unspecified date. She was treated with anticoagulant therapy for the event "blood clot in her lungs". Outcome of event "blood clot in her lungs" recovered on an unspecified date while for all other events was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
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| 51 | 2021-03-31 | deep vein blood clot |
DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basi...
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DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship. However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-04-01 | heart flutter, palpitations |
have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experien...
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have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experiencing heart palpitations/flutter on and off for about 6-7 hours; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247), via an unspecified route of administration administered in left arm on 19Feb2021 13:15 at single dose for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included clarithromycin (CLARITIN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), and statin for cholesterol. The patient previously took the first dose of bnt162b2 (Batch/Lot Number: EL3247), administered in left arm on 27Jan2021 09:15 for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. No other vaccine received in four weeks. The patient has been experiencing heart palpitations/flutter on and off for about 6-7 hours on 23Feb2021 04:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was not recovered.
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| 51 | 2021-04-07 | chest pain |
Pt received 1st dose of Pfizer vaccine on 3/2/2021. Pt was positive with COVID on 3/22/2021. Pt was ...
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Pt received 1st dose of Pfizer vaccine on 3/2/2021. Pt was positive with COVID on 3/22/2021. Pt was admitted to the hospital on 4/7/2021 for chest pain
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| 51 | 2021-04-10 | chest discomfort, chest pain |
Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of p...
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Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of pericarditis. Patient had previously had COVID-19 in 8/2020. Treated with prednisone and colchicine, pain improving on time of discharge.
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| 51 | 2021-04-12 | fainting |
sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a co...
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sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-Year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6204 and expiry date was not provided) via an unspecified route of administration, in left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and immunotherapy. The patient had allergies to penicillin, sulfa drugs and peanuts. The patient's concomitant medications were not reported. The patient previously took ibuprofen and had allergy. The patient stated that On 18Mar2021 at 12:30, the patient experienced sudden severe onset of vertigo and dizziness with syncope and vomiting. The patient was hospitalized for 3 days. On an unknown date in Mar2021, the patient was hospitalized, and a week and a half later still had dizziness which prevents patient from performing daily tasks. Patient received unspecified treatment for the adverse event. Seriousness of the events was reported as hospitalization. Outcome of the events vertigo, syncope, vomiting and loss of personal information was recovering, and for the events dizziness it was not recovered.
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| 51 | 2021-04-13 | fainting, palpitations |
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional D...
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Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 6 days after dose patient had a syncopal attack and severe palpitations. Daughter called ambulance after finding mother had fainted.
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| 51 | 2021-04-15 | heart rate increased, blood glucose increased |
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin...
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Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
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| 51 | 2021-04-17 | loss of consciousness |
passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (pat...
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passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (patient). This 51-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8727) at single dose via an unknown route in left arm on 22Mar2021 09:45 for Covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), levothyroxine, colecalciferol (VITAMIN D 3), cetirizine hydrochloride (ZYRTEC), and fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient passed out on Weds evening 24Mar2021 at 09:00 PM, followed by nausea, vomiting, passing of blood, and stomach cramping and was admitted to the hospital on 25Mar2021. Duration of hospitalization was 5 days. Patient was diagnosed with ischemic colitis. This was a condition she had never had before and considered herself completely fine before this incident. A battery of tests uncovered no reason for the passing out to have happened. Lab data included nasal swab on 26Mar2021: negative. The adverse event result in Emergency room/department or urgent care. It was unknown if treatment received for the adverse event. Outcome of the events was resolving.
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| 51 | 2021-04-20 | loss of consciousness, heart rate increased |
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa...
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All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
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| 51 | 2021-04-24 | hypertension |
A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female ...
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A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date and unspecified if ongoing (not taking meds for this prior to this event) and strawberries - anaphylaxis from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was pregnant. Concomitant medications ("other medications in two weeks") included acetaminophen taken for an unspecified indication from an unspecified date and unspecified if ongoing, as needed. It was unknown whether the patient received any other vaccine within four weeks of the COVID-19 vaccine. The patient experienced a spike in her BP (blood pressure) on an unspecified date ("with her first dose"). The clinical outcome of the event a spike in her BP was unknown. Since the vaccine, it was unknown whether the patient was tested for COVID-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "a spike in her BP" cannot be excluded. The event was confounded by underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-04-30 | blood clot |
Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; Large blood ...
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Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 04:15 (at 51 years old, not pregnant), single dose for covid-19 immunisation. Medical history included stroke, high blood pressure, diabetes mellitus, all from an unknown date and unknown if ongoing. The patient's concomitant medications was unspecified (mentioned other medications in two weeks: yes but prescribed). The patient had her first dose of BNT162B2 vaccine on 26Feb2021 04:15 at 51 years old, for COVID-19 immunisation on left arm. The patient experienced large blood Clotting after each dose during menstral cycle. Bled for more than 2 weeks. All on 27Mar2021 12:00. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No treatment for the events. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 51 | 2021-05-10 | pulse abnormal |
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches...
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Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient). The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization. Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration. After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
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| 51 | 2021-05-13 | vaginal haemorrhage |
bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleedin...
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bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 08Apr2021 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunization. Medical history included endometriosis diagnosed in 1993 and subsequently she had laparoscopy twice by the age of 26-year-old; and ongoing menopause since 2018. History of Parity 1: the patient was pregnant with her daughter and have her naturally at 27 years old and never had another pregnancy again. The patient's concomitant medications were only women multi-vitamins. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she has not had menstrual cycle since 2018. On 23Apr2021, the patient started spotting. Since 26Apr2021, she has been bleeding heavily with small clots. All day today (on 28Apr2021) she has been bleeding very very heavy with clots. She was planning to go to her doctor by morning, but she was following through with her second dose tomorrow (29Apr2021). The clinical outcome of the events "have not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots" were not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 52 | 2020-12-31 | chest discomfort, heart rate increased |
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr...
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Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
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| 52 | 2021-01-01 | heart rate increased |
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2...
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12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
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| 52 | 2021-01-02 | chest pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-04 | heart rate increased |
APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFT...
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APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFTER THAT I FELT A 'RUSH' FROM HEAD TO TOE. ALL OF THIS HAPPENED OVER MAYBE 20 SECONDS - THEN MY HR DECREASED TO NORMAL AND I FELT FINE.
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| 52 | 2021-01-04 | chest pain, palpitations |
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c...
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Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
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| 52 | 2021-01-04 | chest discomfort |
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov...
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Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
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| 52 | 2021-01-04 | palpitations |
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe...
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Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| 52 | 2021-01-04 | blood pressure increased, chest pain |
Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to ...
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Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to neck, chest and abdomen, chest pain, and elevated blood pressure. Patient states she is already on cardiac medications so she took an additional dose for her blood pressure and monitored herself closely.
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| 52 | 2021-01-04 | chest discomfort |
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a c...
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chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.
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| 52 | 2021-01-05 | chest discomfort, palpitations |
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ...
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Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
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| 52 | 2021-01-05 | chest discomfort |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | heart rate increased, blood pressure decreased |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | pallor, palpitations |
PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PA...
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PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT 1420. 120/90. EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER. PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.
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| 52 | 2021-01-05 | heart rate increased | RAPID HEART RATE 150-160, SHAKY FEELING 10 MIN POST VACINATION |
| 52 | 2021-01-06 | heart rate irregular, palpitations, chest pain |
12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. H...
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12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.
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| 52 | 2021-01-06 | blood pressure decreased |
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B...
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Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
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| 52 | 2021-01-07 | palpitations | General Malaise, Light Headed, Palpitations & Nausea |
| 52 | 2021-01-07 | fainting |
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE...
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HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
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| 52 | 2021-01-07 | blood pressure increased, lightheadedness, palpitations |
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ...
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Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
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| 52 | 2021-01-08 | blood pressure increased, hypertension |
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r...
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HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
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| 52 | 2021-01-08 | hypertension |
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h...
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Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
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| 52 | 2021-01-08 | chest pain |
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra...
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after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
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| 52 | 2021-01-09 | blood pressure increased | Turned red in upper torso, swelling to tongue and heightened blood pressure. |
| 52 | 2021-01-10 | fast heart rate |
30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and h...
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30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and headache, worsening over next 15 minutes, with skipped beats. Heart rate was 115 and decreased 93 with breathing exercises for relaxation. Blood pressure was steady at about 190/110 ( she states she stopped her blood pressure medication 3 days prior). she was taken to ED for further evaluation and treatment
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| 52 | 2021-01-10 | chest pain, chest discomfort |
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn...
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Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
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| 52 | 2021-01-10 | fast heart rate, chest pain | tachycardia that is still ongoing with some chest pains |
| 52 | 2021-01-11 | chest pain | Chest Pain 2 weeks after receiving vaccine |
| 52 | 2021-01-11 | chest discomfort |
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir...
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Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
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| 52 | 2021-01-12 | fast heart rate, chest discomfort, hypertension |
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face b...
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After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
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| 52 | 2021-01-12 | chest pain |
Chest pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient...
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Chest pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1 intramuscularly on 07Jan2021 11:00 at a single dose on the right arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The patient received the vaccine at a nursing home/senior living facility. No medications were received within 2 weeks of vaccination and no other vaccines were received within 4 weeks prior vaccination. The patient experienced chest pain on 07Jan2021 12:00. The went to the emergency room/sought urgent care for the event. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of the event was unknown. The event was assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-01-12 | palpitations | dizziness with perceived palpitations; facial flushing and headache |
| 52 | 2021-01-13 | chest pain |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-13 | chest discomfort |
During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling...
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During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling tightness in her chest and feeling harder to breath. Pt reports that this has occurred in the past with other allergic reactions. VS assessed 136/74, HR 105, SPO2 97. Pt transferred to ER for continued monitoring. Patient given dexamethasone, diphenhydramine, famotidine, ipratropium, and ondansetron
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| 52 | 2021-01-13 | palpitations |
IM given@ 9;00am and at 9;08 am pt. begin to c/o palpitaions. VS taken R 22 P70 BP 154/112 sats ...
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IM given@ 9;00am and at 9;08 am pt. begin to c/o palpitaions. VS taken R 22 P70 BP 154/112 sats 99% pt. states has Hx . HTN and she says took her BP medication this morning. VS re-check at 9:15 am BP 153/102 HR 66 Sat 99% R20. Pt states feels better now , denies any more symptoms.
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| 52 | 2021-01-13 | fast heart rate |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-13 | chest pain |
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu...
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Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
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| 52 | 2021-01-13 | fainting | Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium |
| 52 | 2021-01-14 | hypotension |
Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of ...
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Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of receiving vaccine, patient complained of lightheadedness. Vital signs showed slight hypotension which improved with hydration.
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| 52 | 2021-01-14 | blood pressure decreased | onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52 |
| 52 | 2021-01-15 | chest pain, chest discomfort |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-17 | blood pressure decreased |
Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccin...
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Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccine. She denied pain, difficulty breathing or other complaints. She lay down, got a cold compress and felt significantly better
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| 52 | 2021-01-18 | heart rate increased, pallor |
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45...
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After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
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| 52 | 2021-01-18 | blood pressure increased | Lethargy, Dizziness, Shivering , increased BP |
| 52 | 2021-01-19 | hypertension, fast heart rate |
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ...
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Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
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| 52 | 2021-01-19 | palpitations | Heart Racing, Heat rush |
| 52 | 2021-01-19 | heart rate increased |
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE...
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RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
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| 52 | 2021-01-20 | heart attack, chest pain, heart attack, troponin increased |
Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable...
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Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable healthcare professional (patient). This 52-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 07Jan2021, for COVID-19 vaccination. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 1998 and vitiligo from 1988. She was overweight. She had really no other risk factors. Concomitant medications were not reported. On 08Jan2021 the patient experienced heart attack and she had a MI, then a cardiac catherization that was normal and a normal echo as well. She said it was diagnosed as a NSTEMI and not a large MI, the smaller version. These events required hospitalization from 08Jan2021 to 12Jan2021. MI occurred after she finished clinic and she was not standing or doing anything, just sitting and she had chest pain. Her office was right next to the ER, so she received treatment within an hour and they were able to help her. She said that her hospital couldn't do a cardiac cath, so on 11Jan2021 they moved her to an hospital which was another treatment facility. When she had her MI they gave her acetylsalicylic acid (ASPIRIN) and sublingual nitroglycerin. They tested her troponin and did an EKG which was abnormal on an unspecified date in Jan2021. On 08Jan2021 troponin was increased. When they treated her with nitroglycerin and Aspirin, two hours later her EKG was normal and her troponin came down overnight on 09Jan2021, which was when they said for sure that she had a heart attack. The patient said it was very scary to have a heart attack, but thankfully there was not a lot of damage done and she was able to get treatment quickly. She did not think the event was disabling since they did not see much damage to her heart muscle, it was a near miss kind of thing. She said it was life changing in that she will now be on medication forever, she will be on at least a baby Aspirin and probably something like a statin for the rest of her life. She was recovering, it was unknown what the lasting effects may be, she felt normal but tired from her hospital stay. Heart attack resolved on 08Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event acute myocardial infarction cannot be excluded. The contributory role of the patient age and background of obesity cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-01-20 | palpitations |
Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to i...
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Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to injection site; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ELO140), via an unspecified route of administration in left arm on 06Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and brachial radial puritis. Concomitant medication included metoprolol succinate (TOPROL) and estrogens conjugated (PREMARIN). No COVID prior vaccination. No other vaccine in four weeks. The patient experienced mild feeling of throat constricting, dizziness, and palpitations, left arm sore, Circular rash next to injection site on 06Jan2021 14:45 (for about 20 minutes), left arm sore for about 4 days. No treatment received. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
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| 52 | 2021-01-20 | heart rate increased |
Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 ...
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Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 feet achy R arm where got shot - had muscle spasms in back, Body aches, heart rate 110. 1/19/21-worked 1/19/21 no muscle spasms.
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| 52 | 2021-01-20 | pulse abnormal, palpitations |
The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart wa...
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The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart was racing and very shaky. I work at a clinic, so my blood pressure was taken and it was 160/100, pulse was 120. Had a bad head ache and continued to have waves of this for about an hour.
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| 52 | 2021-01-21 | palpitations | Palpitations, Racing Heart |
| 52 | 2021-01-21 | excessive bleeding |
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro...
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Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
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| 52 | 2021-01-22 | chest discomfort |
The night before I felt a heaviness in my chest, trouble breathing and the next morning I felt the s...
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The night before I felt a heaviness in my chest, trouble breathing and the next morning I felt the same. I called my PCP and had a EKG and Covid swab (negative). She prescribed me steroids'.
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| 52 | 2021-01-23 | chest discomfort, fast heart rate |
After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105...
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After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105) and left arm pain. team was called and was taken to the ER.
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| 52 | 2021-01-24 | blood pressure increased |
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue...
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fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 52 | 2021-01-26 | chest discomfort |
11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light h...
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11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light headed had two masks on placed in private room so she could remove masks. 11:21 breathing better masks removed 11:35 b/p 130/90 heart rate 94 breathing easy. Informed to only wear one mask. Instructed to Call 911 for further breathing difficulty.
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| 52 | 2021-01-26 | heart rate irregular, chest pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had ch...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen, and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
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| 52 | 2021-01-26 | chest pain, chest discomfort |
Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a ...
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Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED with RR
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| 52 | 2021-01-26 | atrial fibrillation |
The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib wa...
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The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib was gone
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| 52 | 2021-01-27 | palpitations, chest pain |
By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop ...
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By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop at stop sign, and my daughter in law told me she wanted to drive me because I was scaring her and I was being mean to her, very snappy. The next morning I had a fever 100, muscle ache, heart racing, headache and I stayed in bed all day. I took 2000mg Ibuprofen, 800mg Tylenol, Benadryl 10mg. On the 20th I was still lethargic had body aches and heart was racing, I took 800mg Tylenol that day. The 21st I had dizziness, brain fog, heart racing, lethargic. The 22nd I contacted the work Nurse and let her know what was going on, my heart rate was 140. They told me I was probably having a reaction and would go away in a couple days. On the 24th,25th,26th,27th I started having chest pain, lethargy. I had a clinic visit with my PCP on the 28th and she said my BP was 160/90, I never had BP issues. She ran test. The 29th I still had brain frog, lethargy, chest pain. I could feel my heart beat in my ear especially at night, I have never has BP issues in my life. On the 30th my heart ponding sound was in my ear. January 16th I went to the ER my heart was 130 and BP 187/108, they did a full work up on me. She started me on Metprolol-50mg(extended release). I seen the cardiologist on 1/20 and told me I had left atrial enlargement , mitro-valve regurgitation . I had an echo- cardiogram on 1/25. The medicine has definitely helped me .
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| 52 | 2021-01-27 | blood pressure increased |
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid...
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slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 52 | 2021-01-28 | hypertension, fast heart rate | Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting |
| 52 | 2021-01-29 | blood pressure increased |
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat...
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Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
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| 52 | 2021-01-30 | lightheadedness |
Acute onset of severe left lower quadrant pain leading to near-syncope and collapse. Severe pain las...
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Acute onset of severe left lower quadrant pain leading to near-syncope and collapse. Severe pain lasted 15-20 min, then decreased intensity for about 12 hrs longer. Transported to ER by ambulance.
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| 52 | 2021-01-30 | blood pressure decreased, hypertension, chest discomfort |
Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to ...
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Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to feeling hot with mild chest tightness. She stated she has anxiety and was anxious about receiving vaccine. She confirmed no swelling of the tongue, no SOB, no itching or other signs of anaphylaxis. Pt given diphenhydramine x2 and famotidine x1 along with a cup of water. Pt requested O2 and BP be monitored. O2 sat never below 97, BP was high initially at 153/112. Pt also had jacket on initially. Pt advised to breath and relax. Pt reassessed after 10 minutes. Removed jacket for BP check which had come down to 132/94 which pt states is baseline for her as she does have a bit of high BP. She also reported at that time feeling better and had calmed down. She stated she really felt it was anxiety. She left with instructions to call 911 or seek emergency attention if Sx reoccur.
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| 52 | 2021-01-31 | fast heart rate | Elevated BP, tachycardia, nausea, vomiting, diarrhea, headache, fatigue |
| 52 | 2021-01-31 | fast heart rate |
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil...
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Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
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| 52 | 2021-01-31 | palpitations, increased heart rate, hypertension |
Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Sym...
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Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Symptoms went away without intervention at 30 minutes post injection. Became short of breath with elevated heart rate and blood pressure again approx. 45 min. post injection tat worsened when standing, walking or talking, HR 143 BP 229/127 I was sent to the ED to monitor had a EKG, Benadryl, Pepcid, Then I had sinus tachycardia in ED, stayed until approx. 4 hours past injection. Symptoms resolved at time of DC
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| 52 | 2021-02-01 | chest discomfort |
Day#0 (about 4 hours after vaccination) - Some chest discomfort, shortness of breath. Day#1 - Still...
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Day#0 (about 4 hours after vaccination) - Some chest discomfort, shortness of breath. Day#1 - Still with some chest discomfort, shortness of breath, indigestion, diarrhea. Day#2 - Symptoms much improved.
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| 52 | 2021-02-01 | chest discomfort |
Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortn...
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Patient started tearing up, feeling tingly lips, coughing, and feeling tightness in the chest/shortness of breathe about 10 minutes after receiving her (second) dose of the Pfizer Covid-19 vaccine. She was then sent to the ER where she is given epinephrine IM, benadryl, steroid, PPI, fluid resuscitation, and albuterol/atrovent for her anaphylactic symptoms. She was also given zofran for her coughing and gagging symtoms. About 3 hours later, she had recovered in the ER and was discharged home.
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| 52 | 2021-02-01 | loss of consciousness |
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-co...
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passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-02-02 | chest discomfort, blood pressure fluctuation |
1344 - Received vaccination 1404 - Arrived in medical response/triage area via WC escorted by observ...
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1344 - Received vaccination 1404 - Arrived in medical response/triage area via WC escorted by observation staff with reports of mild mid-sternal chest pressure and moderate dizziness. 1408 - BP 165/77, HR 81, RR 22. MD and multiple RNs at beside. Escorted SO (ex-husband/best friend/roommate) into triage area to be with patient. 1420 - Chest pressure not changed to chest sharpness and radiates slightly to right of mid-sternum. BP 152/84, HR 87, RR 26. 1430 - Called standby EMS 1432 - BP 161/78, HR 86, RR 22 1435 - Standby EMS arrived 1447 - Transport EMS arrived 1454 - Transport EMS left w/ patient and SO for hospital transfer.
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| 52 | 2021-02-02 | fast heart rate, chest pain, excessive bleeding |
Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain;...
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Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-02-02 | cardiac arrhythmia, heart rate increased | Chills PVC slow and fast heartbeat Headache Dizzy |
| 52 | 2021-02-02 | chest pain |
Fever chills severe body aches and joint aches severe headache diarrhea nausea abdominal pain severe...
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Fever chills severe body aches and joint aches severe headache diarrhea nausea abdominal pain severe fatigue some mild chest pain
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| 52 | 2021-02-02 | heart rate increased |
Fever ranging from 100-102, body aches, chills and increased heart rate (110 bpm)--resolved 24-36 ho...
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Fever ranging from 100-102, body aches, chills and increased heart rate (110 bpm)--resolved 24-36 hours after onset
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| 52 | 2021-02-03 | chest discomfort |
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ...
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Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
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| 52 | 2021-02-03 | blood pressure increased |
Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and ...
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Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and vomiting, increased BP 133/77, pulse 110, temp 98.8 F. Symptoms resolved over several hours.
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| 52 | 2021-02-03 | palpitations |
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu...
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Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
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| 52 | 2021-02-03 | blood pressure increased |
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ...
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Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
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| 52 | 2021-02-03 | fast heart rate |
headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat...
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headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin. Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
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| 52 | 2021-02-04 | chest discomfort |
I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; ...
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I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; This is a spontaneous report from a contactable Other HCP (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 1284), via an unspecified route of administration in left arm on 12Jan2021 15:15 at second single dose for COVID-19 immunization. The patient medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication included sertraline. No other vaccine received in four weeks. The patient previously tool first dose BNT162B2 (Lot number: EL 1284) on 22Dec2020 03:30PM in left arm for COVID-19 immunization. The patient had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose. Adverse event start date/time: 12Jan2021 10:15 PM. No treatment received for AE. No COVID tested post vaccination. Outcome of the event was recovered in Jan2021.
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| 52 | 2021-02-04 | palpitations, heart rate increased, cardiac arrhythmia |
Patient reports that her HR is elevated about 15 minutes post Pfizer COVID vaccine #2. HR at 112....
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Patient reports that her HR is elevated about 15 minutes post Pfizer COVID vaccine #2. HR at 112. States she feels a little dizzy. Reports that, during the day, her resting HR is never "this high". Reports that she had COVID and did not have bad symptoms. Recovered from COVID, but then started to get palpitations. States that she has a rapid heart rate that is 120's after that. Follows up with cardiology. Had a Holter monitor, which showed that she had a lot of PVC's. Currently on metoprolol, which she took today. Heart sounds are regular, no murmurs. VSS throughout monitoring. Dizziness resolved after about 20 min. Left facility of her own accord without assistance.
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| 52 | 2021-02-04 | palpitations |
Pt reported heart racing. Denies all other symptoms: chest pain, shortness of breath and respirator...
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Pt reported heart racing. Denies all other symptoms: chest pain, shortness of breath and respiratory symptoms.
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| 52 | 2021-02-06 | heart rate irregular |
1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel so...
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1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel soreness and ache - day#2- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish - day#3- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish, plus irregular heart beat - day#4- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish intensified - day #5- body ache subsided, Headache and nausea continued to feel intensified. Fever now turn into chills - day#6- unbearable headache and worse nausea feeling, chills, need to leave work in the afternoon. Throwed up and shaking. Took many headache medications and antinausea medications but nothing work. 2. 2/5/2021 @1630- received 2nd dose Pfizer COVID 19 vaccine - day#1, 1 hour into receiving vaccine, feeling dizzy and "hangover" type reaction. 2 hours into receiving vaccine, developed irregular heart beats. Left arm injection pain and sore arm. - day# 2: entire body ache, joint pain, headache and nausea - day#3: severe headache and feeling nauseous. Took many headache and antinausea medications. - will continue to follow adverse reactions.
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| 52 | 2021-02-06 | palpitations |
Within hours of vaccine heat began racing. Sustained pulse of approximately 128 for over 12 hours, ...
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Within hours of vaccine heat began racing. Sustained pulse of approximately 128 for over 12 hours, measured via pulse/ox on finger. Didn't go higher so no add'l treatment retained.
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| 52 | 2021-02-07 | loss of consciousness |
As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and wen...
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As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee. She states she woke up 15 minutes later and had lost consciousness. She went to her husband who said her words were slurred. She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
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| 52 | 2021-02-07 | chest pain |
At about 12 pm day of immunization patient began having the following symptoms: redness to neck and ...
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At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest, injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time. En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100. Patient states took additional Benadryl 25mg PO . After Benadryl chest pain subsided. At this time reports headache, dizziness, vertigo, chills , and fever. Vital signs stable, patient aaox3, report to Occupational Health provider. No obvious distress noted.
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| 52 | 2021-02-08 | fast heart rate |
Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approxim...
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Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approximately 11:30am. She felt fine after the second vaccination, until about 1:30-1:45pm. Patient c/o a "heat rush", headache, and hives on BUE. Patient vitals were WNL except HR was slightly tachycardia at 107bpm. Respirations were baseline at 18. Patient denies sob/anaphylaxis. Benadryl administered orally, and monitored. No reaction was had with the first vaccine.
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| 52 | 2021-02-08 | chest discomfort | Trouble breathing, tightness in chest, headache |
| 52 | 2021-02-09 | chest discomfort, heart rate irregular |
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years a...
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History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room. No history of angioedema.
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| 52 | 2021-02-11 | hypertension |
12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice an...
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12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice and cool compress HR 68 RR 16 12:43 feeling "back to normal" Increased sneezing and nasal congestions NKA continue to monitor 13:00 Hr 80 RR 18 SPO2 100% BP 184/89 EE reportedly hypertensive at baseline 13:05 Benadryl 25mg po provided 13:10 Continues to feel "back to normal" Ambulating well. Escorted to parking structur by RN.
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| 52 | 2021-02-15 | blood pressure increased |
Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headach...
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Took Benadryl 30 min before vaccine due to allergies. 30 min after vaccine felt lightheaded, headache. A few hours later was dizzy and had difficulty swallowing and throat was becoming increasingly uncomfortable. Took Benadryl again and headed to hospital. Blood pressure was extremely elevated upon exam. Throat tightness became somewhat improved after Benadryl. Blood pressure improved some after taking BP med. Doctor ruled it allergic reaction to vaccine and sent me home after 5 hours with instructions to take Benadryl every 6 hours as needed.
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| 52 | 2021-02-17 | nosebleed |
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i...
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chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
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| 52 | 2021-02-18 | chest discomfort |
Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching ...
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Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching (full body); Began after 15-20min lasted the remainder of the day and nearly completely resolved the following morning. Delayed Hives (to neck/face above neck); resolved the following morning Delayed injection site soreness; Began 4-5hrs after the injection worsened, extremely tender to touch Following morning the injection site is slightly raised, red to pink, warm to touch, swollen 2-2.5cm in circumference around the injection site, some itching remains. General fatigue 4-5hrs following the injection. Resolved the following morning
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| 52 | 2021-02-18 | blood pressure increased, nosebleed |
On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That even...
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On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That evening I had upset stomach, exhaustion and loose stool. The next day, 2/17/21 I had headache all day and continued exhaustion. In the evening, I took my blood pressure and it was 156/98. An hour later, it was 165/98. By 9:30 p.m it had risen to 172/98 and I was shaking and having difficulty walking/talking. I went to the emergency room. My blood pressure was still 172/98 upon arrival so blood work, EKG, chest X-ray, and CT scan were performed. I was released later that evening when my blood pressure came down to 156/98 . My normal blood pressure is always 120/80 or lower.
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| 52 | 2021-02-18 | fainting | patient felt like she was going to faint, but did not. Transferred by EMS to medical facility. |
| 52 | 2021-02-21 | nosebleed |
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s...
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16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
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| 52 | 2021-02-21 | palpitations | Itching, swelling at injection site, pain, heart palpitations, lymph node swelling |
| 52 | 2021-02-21 | chest discomfort |
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mi...
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Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
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| 52 | 2021-02-22 | arrhythmia, chest discomfort |
"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal...
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"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 . She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered "
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| 52 | 2021-02-22 | fast heart rate |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-22 | hypertension, fast heart rate | Tachycardia/high blood pressure hours after vaccine admitted to hospital. |
| 52 | 2021-02-23 | fast heart rate |
1) injection 2/15 2) chills 2:00 am 2/16 fatigue rest of day 3) rapid heart rate, light headed 9 pm ...
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1) injection 2/15 2) chills 2:00 am 2/16 fatigue rest of day 3) rapid heart rate, light headed 9 pm 2/16 4) rapid heart rate woke me out of my sleep, call EMS, HR 160, BP 156/106, EKG normal. Resolved after 1 hr 5) rested for 2 day with episodes of tachycardia after walking up/down stairs. 6) 2/21 worked 2 hours became lightheaded, HR 106, BP 138/96, went to ER. All labs negative, EKG, negative. 7) continue fatigue 8) tachycardia 2/23 8 pm. lasted 20 min. HR 130
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| 52 | 2021-02-23 | heart flutter |
Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the se...
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Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the second dose of vaccine. The patient was found in her car with husband onscene appearing to be in minor distress. Per the patient she has a history of anxiety and feels that she is having a anxious epsiode. Patient admits to having a similar effect post first dose. Patient admitted to " fluttering in the chest" as well as numbness in the fingers, patient was slightly tachypnic upon inital contact. Patient was advised of calming measures and symptoms began to subside. A full 911 response was started and performed a AMA, Heartland CAD # 2021-00012209. "PFIZER COVID 19 VACCINE EUA"
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| 52 | 2021-02-24 | chest discomfort |
Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on bac...
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Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on back with feet elevated. 911 called. EMS evaluated and pt was better and signed for no transport.
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| 52 | 2021-02-25 | fast heart rate | Numbness in jaw, lips, neck on left side. Tachycardia |
| 52 | 2021-02-27 | chest pain | SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS |
| 52 | 2021-02-28 | heart rate increased |
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm...
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Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
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| 52 | 2021-02-28 | fainting, heart rate increased | Fainted Fast heart rate Headaches Dizziness |
| 52 | 2021-03-02 | fast heart rate, palpitations |
Tachycardia, palpitations, chills. BP 182/114 (pulse 121), O2 sat 98%. F/u BP 179/108. Given Benadry...
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Tachycardia, palpitations, chills. BP 182/114 (pulse 121), O2 sat 98%. F/u BP 179/108. Given Benadryl 50 mg PO, ASA 325 mg.
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| 52 | 2021-03-02 | palpitations, chest pain |
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a...
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chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
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| 52 | 2021-03-03 | loss of consciousness |
Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight ...
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Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight Day 2, 27 Feb 2021: 103 fever for 3 hours, reduced and maintained at 100 with alternating extra strength Tylenol with 800 mg Motrin every 4 hours; continued severe fatigue; continue headache, nausea started at 5:00 pm Day 3, 28 Feb 2021: Nausea, diarrhea, muscle pain, vomiting, headache, 100 degree fever for 24 hours, 6:00 pm passed out for less than 1 minute when standing to go to bathroom to vomit (aware, controlled fall); 2nd episode of passing out sometime after midnight, tried to stand, completely blacked out, woke up disoriented, called 911, transported to ER; bruised upper left arm, left side jaw/neck hitting furniture in fall, hit head on floor
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| 52 | 2021-03-04 | heart rate increased |
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021...
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At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
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| 52 | 2021-03-04 | palpitations |
Patient complaining of heart palpitations that started 24 hours after the administration of the vacc...
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Patient complaining of heart palpitations that started 24 hours after the administration of the vaccine. Patient still having palpitations today, patient states that the intensity of the palpitations have decreased since they first started on 3/2/2021. Patient also complained of shortness of breath that started first at rest and then the patient noticed that when going up the stairs she felt really out of breath that she had to lay down and rest. Patient also had two episodes of dizziness on 3/4/2021.
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| 52 | 2021-03-04 | loss of consciousness |
Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes...
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Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes noticed eye sensitivity and headache. When symptoms did not pass after an additional 10 minutes she came back into the office. While waiting when her husband was checking her in, she "passed out." Episode lasted less than 1 minute. She was easily oriented to person, place and time. It was noted that she had some swelling to bilateral eyes. Patient was brought back to room, VS were checked and all were normal. She denied any chest pain, shortness of breath, wheezing, tongue swelling, itching, or tickling sensation to back of the throat. She was able to tolerate sips of water without difficulty. 50mg benadryl IM was given in the left deltoid. Approximately 5 minutes after IM injection patient again "passed out." She was seated at the time and slumped to her right, resting her head on her husband and did not fall from chair. She aroused after approx 2 minutes, and was a/ox4. VS were rechecked and were O2 99% on RA. HR 101, BP 124/88, RR20, temp 98.5/oral. Patient stayed at the clinic for an additional 45 minutes after which her eyesight was reported to be back to normal, her headache had improved and the lower eye edema had resolved. It should be noted that both the patient and the husband were not concerned with her "passing out." She states it happens because of pain and she was fearful of the injections. Patient also states that her neurologist told her that when "she is in too much pain, she will pass out."
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| 52 | 2021-03-04 | body temperature decreased |
aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that...
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aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.
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| 52 | 2021-03-04 | palpitations |
palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; ...
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palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event "Soreness for 2.5 days" was recovered; "She felt pain immediately from the injection", "it is red and bruised/Redness" was recovering; and "bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple", "Warm to touch/feels hot to touch" and "Swelling in the injection area" was not recovered, and for palpitations was unknown.
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| 52 | 2021-03-05 | palpitations |
Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore ...
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Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore calf Sore quad Sore arm (injection site) Sore neck left side. Fatigue
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| 52 | 2021-03-07 | heart rate increased |
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,...
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03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
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| 52 | 2021-03-07 | blood pressure increased, fast heart rate |
Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She ...
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Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She reports she felt a little run down on Saturday (the following day of the injection). She feels well today. Denies any further questions or concerns. Pt is appreciative of phone call. Progress Notes Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes Family Medicine Cosigned by: Expand AllCollapse All STORMONT VAIL COVID VACCINE CLINIC DOB: 2/1/1969 Date: 2/26/2021 a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: anxiety/panic attacks. HTN on amlodipine since 3-4 months. 10 mg. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, dizziness and headaches Feels flushed and hot Not diaphoretic: Previous Reactions: none. States she was anxious prior to her visit today about the vaccine. Objective Vitals Vitals: 02/26/21 1326 02/26/21 1336 02/26/21 1339 02/26/21 1351 BP: (!) 155/96 (!) 187/121 (!) 156/97 (!) 154/97 Patient Position: Sitting Pulse: (!) 109 99 Resp: (!) 24 SpO2: 100% 100% Physical Exam Constitutional: General: She is in acute distress (anxioius affect). Appearance: She is obese. Cardiovascular: Rate and Rhythm: Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Tachypnea (slightly 24) present. Comments: Pt asked to remove mask to reduce her hyperventilation. Neurological: Mental Status: She is alert. Psychiatric: Attention and Perception: Attention normal. Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Comments: Tearful and slightly anxious Assessment/Plan Treatment included: water, snacks and ice pack Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) (elevated blood pressure) Pt observed approx 30 minutes. Pt improved in symptoms after rest, food, water and ice pack. Her bp was coming down. HR and RR normal. Pt felt better. She wanted to leave as staying here is making her more anxious. Recommended that she monitor her bp at home. If persists to be elevated of 140/90 that she follow up with her pcp. Pt voices understanding. Pt has co-worker here with her whom walked out with her.
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| 52 | 2021-03-07 | loss of consciousness |
Within minutes after vaccine, became dizzy, shaky, stated felt nasal congestion, reported she has bl...
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Within minutes after vaccine, became dizzy, shaky, stated felt nasal congestion, reported she has blood pressure, then passed out. Called for Paramedics and assisted to floor, elevated legs, monitored symptoms, no swelling noted, continued to breathe normally throughout with 100% oxygenation and came back to consciousness within a minute. Paramedics responded. Stable, pt agreed to be transported to local ER for further evaluation.
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| 52 | 2021-03-10 | heart rate increased | diaphoretic, elevated HR, dizziness, "throat closing". Evaluated by EMS-Cleared |
| 52 | 2021-03-11 | pallor |
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stat...
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Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
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| 52 | 2021-03-11 | palpitations, fast heart rate |
Dizziness, light headedness, tachycardia Patient w/ co dizziness, lightheadedness, and palpitation...
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Dizziness, light headedness, tachycardia Patient w/ co dizziness, lightheadedness, and palpitations immediately after receiving her first covid vaccine dose. Hx of hypertension, per patient controlled. Patient immediately brought to medical triage and evaluated by medical personnel.
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| 52 | 2021-03-12 | heart rate increased |
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse...
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10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling, I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml, I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
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| 52 | 2021-03-12 | chest discomfort |
21 minutes after the vaccine I experienced a wave of light-headedness, while I was driving home. I ...
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21 minutes after the vaccine I experienced a wave of light-headedness, while I was driving home. I have had headaches, relieved by Tylenol or Advil, and I have had an intermittent feeling like icy hot in my chest.
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| 52 | 2021-03-12 | heart rate irregular |
I felt a little funny about an hour after the vaccine and then that seem to pass, I went to bed and...
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I felt a little funny about an hour after the vaccine and then that seem to pass, I went to bed and was awoken by an erratic heart beat
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| 52 | 2021-03-13 | loss of consciousness, fainting |
I had a sudden syncope episode with LOC as I walked to my bedroom. Didn't wake up until my head hit...
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I had a sudden syncope episode with LOC as I walked to my bedroom. Didn't wake up until my head hit door jam and I was on the floor.
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| 52 | 2021-03-13 | heart rate increased, chest discomfort |
Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 ...
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Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 min Heart Rate increase 25 min Pressure on chest 25 minutes Severe shivers-30 minutes
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| 52 | 2021-03-13 | fainting |
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va...
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This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
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| 52 | 2021-03-14 | hypertension |
Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ib...
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Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ibuprofen and something for nausea on Friday the 12th of March.
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| 52 | 2021-03-15 | inflammation of the pericardium, chest pain |
Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over he...
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Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over her shoulder and around her neck. Pain worsened during the day, went to ER, found to have positive troponins and subsequent ecg were abnormal. Echo was negative and angiogram showed no blocked arteries. Cardiologist diagnosed her with pericarditis
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| 52 | 2021-03-16 | hypertension |
I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has con...
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I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has continued on to my second dose vaccine. On 12-23-2020 after my first dose I started to have daily headaches. I received my second vaccine in 01-08-2021, also experienced daily headaches. I went to see my PCP on 02-19-2021 who referred me to a neurologist. I saw a neurologist on02-22-2021 and was diagnosed with occipital neuralgia and migraine headaches. I tried different medications but they have not yet worked. I also had a occipital nerve block with no improvement. My BP is high probably secondary to the pain and anxiety I experience from my daily headaches. Today I am still having the daily headaches.
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| 52 | 2021-03-16 | palpitations |
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ...
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Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
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| 52 | 2021-03-17 | palpitations |
3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especia...
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3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especially face and arms), palpitations, dizziness, shaking chill at a time. I called 911 and went to ER. I got an IV. My symptoms were getting minor and I went home. The doctor said my symptoms are from a bad reaction to the medicine," Adverse Drug Reaction". I still have numbness on my face(left side cheek) a little bit.
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| 52 | 2021-03-17 | chest discomfort |
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper...
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ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
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| 52 | 2021-03-17 | chest discomfort, palpitations, chest pain |
After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was...
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After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was getting a cold, my face was hot. I went to the station to take my temperature, it was 98.4F and then I did a re-check 15 minutes later it was 97.2F. I was still feeling under the weather and left work a little before 5pm. I started to drive to the pharmacy when I got there I felt dizzy, I still went in and bought Tylenol cold and flu PM. When I got home, I still was feeling bad, I had severe headaches, migraines and also pain to base of my neck and my chest felt very heavy, like someone was sitting on top of me. I then went to bed early, was lying flat on my bed when I started to feel my heart, shaking my whole body. I felt really scared, these were strong palpitations. I then woke up around 3am, still having persistent headaches 10/10 pain level. I woke up because I could not sleep and went to my living room, still having chest pain and pain in my neck with headaches that did not go away. My BP in the morning was high for me was 132/96, then 133/98 and at 730am it was 137/100 with a pulse of 80. I went to the emergency room where I received IV medication, blood tests, triponents and EKG were performed which came back negative. After an hour of my iv medication, I still continued with headaches, neck pain and my blood pressure was still high. My doctor said that i had a severe reaction to the vaccine. I was discharged to go home after a few hours and I rested then I slowly started to fee better.
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| 52 | 2021-03-17 | chest discomfort | Tightness in chest, short of breath. Assessment VS B/P 142/78, HR 62, O2 Sat 100%. |
| 52 | 2021-03-17 | pallor |
patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pres...
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patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pressure 79/41 mmHg, heart rate 45-50 beats per minute. Patient reports not eating eating anything yet that day. On arrival to emergency department (ED) patient was awake, alert, and oriented. No respiratory, gastrointestinal, or respiratory symptoms noted. Administered diphenhydramine and IV fluids. Patient's symptoms and vital signs improved and discharged to home stable.
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| 52 | 2021-03-18 | heart rate increased |
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue...
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Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
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| 52 | 2021-03-19 | hypotension, fast heart rate |
Lightheaded, hypotension, tachycardia the day after dose #2, similar to what I experienced during an...
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Lightheaded, hypotension, tachycardia the day after dose #2, similar to what I experienced during and following COVID infection in 3/2020. These symptoms lingered x 9 months (~ December) then fewer episodes of intermittent tachycardia (120?s at rest) w/o lightheadedness or hypotension.
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| 52 | 2021-03-20 | cerebrovascular accident |
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability t...
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SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
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| 52 | 2021-03-21 | blood pressure increased |
After rest and water, pt bp decreased, still not normotensive. Pt felt like her dizziness was subsid...
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After rest and water, pt bp decreased, still not normotensive. Pt felt like her dizziness was subsiding until we stood her up. BP increased. Pt sat back down, given more water, pb and cracker and lozenge. 11:21--pt reports lightheadedness is mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp reported. Pt feels well overall otherwise.
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| 52 | 2021-03-21 | palpitations | Patient c/o feeling like heart is racing and not feeling well. Vitals and Assessment normal. |
| 52 | 2021-03-21 | lightheadedness |
Patient described feeling a "fluttering feeling" in her stomach. Vital signs were taken and shown BP...
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Patient described feeling a "fluttering feeling" in her stomach. Vital signs were taken and shown BP 148/108; heart rate 88. Temperature 100.5. Patient stated she felt like she might pass out. Patient's head lowered and she experienced a vasovagal reaction 2 minutes following vaccination. After recovery, the patient was given a granola bar and a bottle of water. Patient's symptoms improved after 30 minutes. Patient was released home with her husband.
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| 52 | 2021-03-21 | hypotension, lightheadedness |
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recip...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient developed dizziness, near syncope, and hypotension. They were seen by EMS and given fluids then transported to emergency department. They were discharged to home the same day.
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| 52 | 2021-03-21 | chest discomfort | c/o chest tightness, throat swelling and flushing |
| 52 | 2021-03-22 | hypertension, blood pressure increased |
Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular u...
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Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular use cuff and was 210/175 and tinnitus used to wax and wane in past but no problems, and this acute on chronic onset was severe, 24/7, non-stop and interferes primarily with sleep. Very loud non-stop bilateral tinnitus. I treated elevated BP for 2 weeks with Losartan 25 mg qd, then daily BP came back to normal and Losartan stopped. Tinnitus has not changed.
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| 52 | 2021-03-22 | chest pain | shortness of breath, difficulty swallowing, headache, chest pain, anxiety, and tremor |
| 52 | 2021-03-23 | chest discomfort |
The patient began feeling as if her chest was tight and she was going to have an anaphylactic reacti...
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The patient began feeling as if her chest was tight and she was going to have an anaphylactic reaction similar to the last time she had one.
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| 52 | 2021-03-24 | chest pain |
After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was tak...
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After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was taken into an exam room, EKG performed and reviewed by Dr. EKG was normal however given patients previous history and symtoms, 911 was called and patient was transported to the Hospital. Patient was later discharged based on "suspected anxiety and perhaps minor reaction to vaccination are at play here."
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| 52 | 2021-03-24 | chest discomfort, heart rate increased |
Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm...
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Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm off and on. Rapid heart rate with chest pressure and sweating (measured 129) at about 5pm day 3. Lasted 25 minutes. Severe irritability at about 8am day 3 and ongoing
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| 52 | 2021-03-25 | chest pain, heart rate increased, chest discomfort |
Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day sin...
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Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day since, I have had chest pain/pressure, sharp pains in my head accompanied by a burning sensation throughout the top and back of my head and a burning sensation throughout my upper back and arms.
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| 52 | 2021-03-25 | chest discomfort |
Chills, chest pressure, fatigue, body aches, headache, fever, lingering headache and spinal, neck a...
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Chills, chest pressure, fatigue, body aches, headache, fever, lingering headache and spinal, neck and shoulder aches and loss of appetite. 48 hours from first symptoms almost fully recovered. First symptoms came on 10-11 hours after vaccine. I was active all day after an am vaccine. Evening I was hit by the vaccine freight train.
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| 52 | 2021-03-25 | blood pressure fluctuation, chest discomfort |
Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:...
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Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:25. V/S: HR 78, BP 133/76, RR 12. At 3:40pm, client reported diminishing symptoms and no new symptoms reported. At 3:50pm, client left site unassisted and with a steady gait, accompanied by husband. No medication provided
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| 52 | 2021-03-25 | chest pain |
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l...
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Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
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| 52 | 2021-03-25 | heart rate increased |
Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster...
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Immediately after receiving the vaccine I felt A rush in my body and my heart started beating faster and my lips began to tingle. The nurse gave me 25 mg of Benadryl and I also am experiencing itching all over my body.
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| 52 | 2021-03-26 | chest discomfort, loss of consciousness, pallor |
After 30 minutes of observation, patient started to leave and didn't feel good. Her face complexion ...
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After 30 minutes of observation, patient started to leave and didn't feel good. Her face complexion turned white and said her chest started to get tight. Staff couldn't get a BP reading. Patient was lowered to the ground as she passed out. An Epi Pen was administered at 11:02am and she woke up immediately. Patient was slowly transferred her to a stretcher and monitored her vitals until EMS arrived at 11:20am. Patient refused to go to hospital after being observed by EMS and her husband came to pick her up.
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| 52 | 2021-03-26 | chest discomfort |
Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, thr...
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Vaccine given , symptoms started 1150 am, Itching, rash, lips "like bee stings", chest pressure, throat scratchy. 10 minutes after vaccine administered. Benadryl 50mg and Epineprhine pen 0.3ml. Symptoms continued until EMS picked her up at 1231pm
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| 52 | 2021-03-28 | palpitations | BP 179/75, O2 100%, HR 124. Palpitation Exit 2:55 pm |
| 52 | 2021-03-28 | chest discomfort, loss of consciousness |
Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath ...
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Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes. Normally do 30 minutes and can speak through it. Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades. Husband told me I was moaning throughout the night and turning from side to side. Got up to go to the bathroom once and head felt foggy. Morning got up as usual and quickly became light headed. Started to black out to the point where sitting down and putting my head down didn?t help. Was blacked out and yelled for my husband. Husband carried me to the couch what I was saying he thought I was hallucinating. Began to have whole body trembling - not necessarily chills just trembling. After about an hour subsided. Blacking out lasted on and off throughout the day. O2 stats between 91 and 94 throughout the day, fast heart rate 90+. No fever. Stayed in bed all day, barely moved. Restless and couldn?t get comfortable - very bad headache. Going in and out of sleep. Treated with Tylenol arthritis and ibuprofen. Drank water and some hot tea. Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
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| 52 | 2021-03-28 | cardiac arrest | Patient had fever after vaccine then later in the day suffered a cardiac arrest |
| 52 | 2021-03-30 | oxygen saturation decreased |
high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of...
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high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of her neck to her butt); butt muscles hurt really bad; caller's spinal column hurt the worst, the front of her calves and hip joints; spinal column hurt the worst, the very edges of her back, the side of her back was excruciating; Dizziness; Vomiting; not feeling well enough; shaking; shivering/ chills; pulse ox and it dropped down to 93; Excruciating body pain; Headache; sore arm / front of her calves, front of her thighs, left arm, 3 left fingers; Exhaustion; no appetite at all; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 08Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing epilepsy since Oct2015 (officially diagnosed in Oct2015, but the doctors believed it was in her early 20s but she was misdiagnosed for decades), post-traumatic stress disorder (PTSD) from 2020 (diagnosed a year ago), sleep apnea since 2016 (patient thought she was diagnosed in 2016), COVID-19 in Nov2020 from which the patient almost died, memory loss (left over COVID symptom) for which the patient was in speech therapy, intermittent body pain (aftereffects of COVID-19), relapse in seizures due to COVID-19, her eyesight was terrible, epilepsy migraines. Concomitant medications included unspecified epilepsy medications. There was no other vaccine given on the same day, or 4 weeks prior to the vaccination. The patient previously received a flu shot and fainted, on an unspecified date. On 08Mar2021 at 11:15, the patient experienced sore arm (pain 2/10). On 08Mar2021 at 22:00, the patient had headache which got progressively worse, then it got so bad she wanted to pop her head off at midnight. On 09Mar2021 at 00:00, the patient had shaking and shivering where it looked like she was convulsing (she had history of epilepsy and knew what a seizure felt like, her husband may have thought she was having a seizure). The patient had chills to the point where she had multiple blankets and could not stop shaking, took her pulse ox and it dropped down to 93. The caller's baseline temperature was 97.1 and her daughter took her temperature and it was 98.9, most people wouldn't consider that a temperature, but it was a temperature for her. The caller kept shaking like that for hours. On 09Mar2021 between 21:00-23:00, the patient had chills again. On 09Mar2021, the patient experienced excruciating body pain (pain 9/10) in very specific parts of her body. On 09Mar2021 by 12:00, the caller's spinal column hurt the worst, the front of her calves and hip joints, the very edges of her back, the spine from the top of her neck to her butt and then next to it was not so bad but the side of her back was excruciating, the butt muscles hurt really bad, the front of her thighs, left arm, 3 left fingers, but not the other 2 fingers. Oddly enough, she was considered a long hauler, it was the places that her occupational therapist and physical therapists were working on. On 09Mar2021 at 00:00, the patient experienced dizziness (that was on and off all day until bedtime last night on 09Mar2021) and vomiting (she couldn't hold down water). On 09Mar2021, the patient was not feeling well enough. On 10Mar2021 at 08:00, the patient experienced diarrhea (she's only gone to the bathroom twice). On Mar2021, the patient experienced exhaustion and no appetite at all. On an unspecified date, the patient experienced a high level of shortness of breath (patient was unsure if this was due to COVID-19). The patient underwent laboratory tests and procedures which included an echocardiogram on an unspecified date: her left atrium was enlarged and her cardiac numbers were high, they were going to monitor her heart and the doctors didn't know if it was because she had COVID-19 or if it was that the doctors got lucky and found it, they had nothing to compare it to because she only had this one echocardiogram. The patient had history of epilepsy migraines (can pinpoint the spot where it hurts), she thought she would try sumatriptan succinate (IMITREX) for this headache (her whole head hurt), as it didn't interact with her other medications. The patient also took acetaminophen/diphenhydramine (TYLENOL PM; Lot: GF6062, Expiry: Jun2022), ibuprofen (patient thinks the Lot is QWE2546A, but is unsure) for the headache. The patient took ondansetron (ZOFRAN) which she had from a previous prescription and that made the vomiting stop. The events did not require an emergency room or physician office visit. The patient did not think that the reactions were due to her epilepsy medication. The clinical outcome of excruciating body pain was resolved on 09Mar2021 (it's hard for the caller to say if she has recovered because she had COVID-19 aftereffects and had body pains that come back intermittently), sore arm / front of her calves, front of her thighs, left arm, 3 left fingers, shaking, shivering/chills, pulse ox and it dropped down to 93, spinal column hurt the worst (the spine from the top of her neck to her butt), butt muscles hurt really bad, caller's spinal column hurt the worst, the front of her calves and hip joints, spinal column hurt the worst, the very edges of her back, the side of her back was excruciating, dizziness, vomiting, not feeling well enough, no appetite at all was resolved on 09Mar2021; headache was not resolved (unless the caller was asleep, she felt the headache); exhaustion was not resolved; diarrhea and high level of shortness of breath was unknown. Information on the lot/batch number has been requested.
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| 52 | 2021-03-31 | low blood platelet count |
pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; c...
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pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization. Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 52 | 2021-04-06 | hypertension, fainting, fast heart rate |
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ...
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fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-04-06 | blood glucose increased, fainting |
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any...
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weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
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| 52 | 2021-04-08 | heart rate increased, hypertension |
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu...
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Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
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| 52 | 2021-04-09 | palpitations, fast heart rate, chest pain |
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up;...
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got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.
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| 52 | 2021-04-13 | fibrin d dimer increased, chest discomfort |
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COV...
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PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
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| 52 | 2021-04-14 | chest discomfort |
Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "...
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Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "throat tightness and difficulty swallowing" and returned to observation area with husband. Client also reported chest pressure while walking to observation area. Client reports this also happened with first COVID vaccine 3 weeks ago. Vital signs stable, able to have conversation and answer questions. RN offered Benadryl, client declined. Chest pressure resolved, throat tightness stayed the same. Client left home with husband.
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| 52 | 2021-04-14 | blood pressure increased, palpitations |
Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was ra...
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Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was racing, and feeling not well. Patient took Benadryl for the nausea and stated she felt slightly better. Patient was advised by doctor, if blood pressure increases to take Metoprolol which she took half a dose. EMT was called and patient blood pressure was elevated and they could not get blood pressure to drop. EMT advised patient to go to the emergency room and EMT escorted patient.
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| 52 | 2021-04-17 | nosebleed |
Blood was coming out both nostrils and down throat and could not be stopped without intervention; we...
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Blood was coming out both nostrils and down throat and could not be stopped without intervention; went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention; Bruising also noticed on arm and leg; This is a spontaneous report from a contactable HCP (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergic to penicillin (body rash). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) for Allergy pills and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 in arm left on 04Mar2021 (lot number: EN6198) for covid-19 immunization. The patient experienced blood was coming out both nostrils and down throat and could not be stopped without intervention, went to emergency room with gushing bloody nose that would stop, bruising also noticed on arm and leg on 30Mar2021 16:00. Reported as: On Tuesday 30Mar2021 went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention. Bruising also noticed on arm and leg. Bleeding resumed after returning home from ER, used Afrin to stop (Afrin up both nostrils). Now stabilize. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected; Sender's Comments: The events "blood was coming out both nostrils and down throat" most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 52 | 2021-04-18 | chest pain, platelet count decreased |
52-year-old woman with no significant past medical history who presented with bruising on her upper ...
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52-year-old woman with no significant past medical history who presented with bruising on her upper and lower extremities - non traumatic. Was found to have platelet count of 3000. Was admitted and transfused 1 unit of platelets. She was reporting chest pain but Chest CT angio negative for pulm embolism. Leg US neg for DVT. Post transfusion counts increased to 55K but slowly drifted down to 24K. She was given pulse dexamethasone. Count 30 K on discharge.
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| 52 | 2021-04-19 | platelet count decreased |
I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 o...
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I received Pfizer dose 1 on 3/17/21 I received Pfizer dose 2 on 4/7/21 The following weekend (4/10 or 4/11) bruises began appearing on my legs. A very large round shaped swollen bruise appeared on my forearm. I work in an elementary school and our school nurse noticed the bruise on my arm and asked how it happened. I told her it just appeared and that I had them on my legs too. She looked at them and told me I needed to get in touch with my doctor ASAP. He sent me for blood work Thursday morningat 7:00 am on 4/15/21. At 4:30 pm that same day I received a call from my PCP office telling me to get to the ER because my platelet level was dangerously low and I was a risk for brain bleed. Got to the ER and my platelets were at 3,000. I received a platelet transfusion and platelets went to 55,000. Next day they were down to 46,000. Next day down to 24,000. Steroids started and Sunday my count was at 30, 000 and they let me go. Got blood work done today to see where I stand.
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| 52 | 2021-04-20 | excessive bleeding, troponin increased, pulse abnormal |
COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; head...
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COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event "GI bleed" was fatal, the event "chest pain" and "body aches" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed
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| 52 | 2021-04-23 | chest pain |
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e...
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All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
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| 52 | 2021-04-26 | blood clot |
swelling in her right foot and right calf and pain/blood clot was diagnosed in her right calf under ...
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swelling in her right foot and right calf and pain/blood clot was diagnosed in her right calf under her knee; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in left arm on 31Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient previously received the first dose of bnt162b2, at the age of 52-year-old, via an unspecified route of administration, administered in left arm on 10Mar2021 11:15(Lot Number: EN6206) as single dose for covid-19 immunization. Started experiencing swelling in her right foot and right calf and pain 3 days following 2nd injection (03Apr2021). Went to the doctor and blood clot was diagnosed in her right calf under my knee 9 days following 2nd injection (09Apr2021). Event resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment for event was 21 Days Xarelto BID then Pradaxa for 90 days. The patient was not pregnant. The outcome of the event was recovering.
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| 52 | 2021-04-27 | blood pressure increased |
Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruatio...
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Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruation period with severe multi-day cramps; Fluid in the ears causing dizziness and elevated blood pressure; Fluid in the ears causing dizziness and elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). This 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 at 14:45 (at age 52-years-old) as a single dose for covid-19 immunisation. Medical history included facioscapulohumeral (FSH) muscular dystrophy from an unknown date and unknown if ongoing and drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; and metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps. The adverse events resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure measurement (30Mar2021): elevated. Therapeutic measures taken included unspecified medication. Clinical outcome of the events fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 52 | 2021-04-27 | pulmonary embolism |
Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covi...
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Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration on 20Mar2021 12:00 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included allergies wherein she mentioned that her allergies were acting up so she took Tylenol 500mg, 1 pill; and insomnia. Concomitant medications included paracetamol (TYLENOL) taken for hypersensitivity; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity, start and stop date were not reported; and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for insomnia (it helps her sleep at night), start and stop date were not reported. It was reported that the patient already received 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and was scheduled to receive the 2nd dose on 17Apr2021. Yesterday, she tested positive for Covid and got hospitalized. She said she got discharged today and is now on medication which includes a blood thinner. She wanted to know if she needed to reschedule her 2nd dose, and how. It was clarified that the patient had Covid test on 12Apr2021 with Positive result. She mentioned that she was reading paperwork and it said something about to let her vaccination provider know about medical conditions, allergies, bleeding or if she take blood thinners. She stated that she was prescribed blood thinners yesterday evening and she was going to be taking them for 3-6 months. She questioned if it was going to affect if she takes the shot on Saturday. She added that she will be on the blood thinner 5-6 days by then. She stated that she was tested for Covid in the hospital that she went in with shortness of breath and they did the test yesterday. She had shortness of breath Saturday (09Apr2021) and she went to the ER on 12Apr2021 and was admitted and was released 13Apr2021. She stated that she was diagnosed from being discharged with blood clots and she is now on a blood thinner and a steroid pill for inflammation. She clarified that she was diagnosed on 12Apr2021 with pulmonary embolism and was put on ELIQUIS and will take it for the 1st 7 days, 2 tablets twice a day and they are 5mg each and then she will take 1 tablet twice a day until she follows up with her primary doctor and will either stop taking it at 3 months or 6 months. She will also be taking Dexamethasone 2mg tablet taking 3 tablets once a day for 8 days. She stated that they did a C scan to identify blood clots. There was no other vaccine administered on the same date the Pfizer vaccine was given. The outcome of events was unknown.
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| 52 | 2021-04-28 | transient ischaemic attack |
TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm...
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TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm was numb, heavy and weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208, expiration date not reported), via an unspecified route of administration on 17Mar2021 (at the age of 52-years-old), 8:00am at single dose in the left arm for COVID-19 immunisation. Medical history included hypothyroidism and ADHD (attention deficit hyperactivity disorder). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 88mg and lisdexamfetamine mesylate (VYVANSE) 40mg both taken from unknown dates and unknown indication. The patient previously took clarithromycin (MACROBID) and experienced allergies. Historical vaccine included first dose BNT162B2 (brand: Pfizer) received on 24Feb2021 6:00pm (lot number: EN6202) at the age of 52-years-old in the left arm. It was reported that on Thursday, 08Apr2021 at approximately 7:00pm, the patient was standing in her kitchen when all of a sudden, a rush of numbness came over her whole left arm. The patient's arm was numb, heavy, and weak. She knew that this feeling was not normal, so she had her husband take her to the hospital, their local hospital. They arrived at approximately 7:30pm where the patient was took in right away. At that time, the feeling had returned to the patient's arm. The patient was taken back for a CAT scan on her head after which the doctor came to tell her that they would be keeping her overnight for observation since they think she had TIA (transient ischaemic attack). The patient was monitored overnight and at 6am the next day on 09Apr2021, she had an ultrasound on her carotid artery and later in the morning, at around 10am, the patient had an echo cardiogram. The patient was released at approximately 12pm on Friday, 09Apr2021. The events experienced resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization from 08Apr2021 to 09Apr2021". The patient has no COVID prior vaccination and had not tested for COVID post vaccination. Outcome of all the events was recovering.
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| 52 | 2021-04-28 | blood clot |
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen...
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blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 52 | 2021-04-30 | inflammation of the pericardium |
Pericarditis, inflammation of the pericardium around the heart; This is a spontaneous report from a ...
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Pericarditis, inflammation of the pericardium around the heart; This is a spontaneous report from a contactable consumer who reported for herself, a 52-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO151), via an unspecified route of administration, administered in right arm on 01Apr2021 at 18:00 (at the age of 52 years old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. There were no medical histories nor concomitant medications. The patient previously received the first dose of BNT162B2 on 10Mar2021 at 06:00 PM (lot number: EN6206), at the age of 52 years old, administered in the right arm for COVID-19 immunization. The patient had no other vaccines in four weeks. The patient experienced pericarditis, inflammation of the pericardium around the heart on 14Apr2021 at 16:30. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if treatment was received for the event. The outcome of the event was recovering.
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| 52 | 2021-04-30 | blood clot, nosebleed |
big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blo...
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big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blood clots coming out of nose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 (Batch/Lot Number: EW0151) as single dose, for covid-19 immunization. Medical history included ongoing sjogren's syndrome and ongoing lupus. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. 07Apr2021, she started having a nose bleed. She explains she wasn't doing anything in particular, just talking on the phone, and blood just started pouring out of her nose. Blood clots started coming out as well. She ended up calling 911 and they sent an ambulance. The EMS helped her stop the bleeding. She didn't go to the ER or anything. However, she is getting implants done for her upper teeth so she wanted to double check and make sure nothing was pressing against her nasal cavity because the nose bleeds were so off/random. The doctor said there was no pushing. The doctor completed a panoramic exam/x-ray and confirmed there was nothing pushing. The doctor did suggest she go to the ENT. She made an appointment with an ENT doctor for the following day, 08Apr2021, and the ENT put a camera down. She confirms she explained to them she just had the vaccine and she was googling information. She was told to not google anything and to let them check it out. The caller states she explained to the ENT the reason she was there was because she was concerned, she is not a nose bleeder and nose bleeds never happened to her. Once blood clots started coming out that way, she was terrified. They didn't see anything alarming, but they wanted to make sure and do further research, so basically they planned to do a CT/CAT scan. She was scheduled for a CT/CAT scan on Monday, 12Apr2021, but she was allergic to the contrast and was sent home because they were not prepared for pre-medication. She is waiting for the doctor to schedule another appointment so she can go back. She felt she needed to report these nose bleeds because she has been seeing Johnson & Johnson had severe blood clots, but she took Pfizer's vaccine, and was also getting blood clots. Her nose bleeds just happened right after both vaccines. On an unspecified date, she had a little bump that went away. She had this big bump on her arm and a big rash developed. At first, the bump was the size of a quarter and then grew double in size. The bump finally went down, but the rash she can still see. The rash hasn't grown, it's just there- there is just a red blotch on her arm. She has not had another nose bleed since the one that occurred on 07Apr2021. She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. The outcome of events was unknown.
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| 52 | 2021-04-30 | deep vein blood clot |
diagnosed with DVT/slight pain in right calf/severe pain in right calf (unable to weight bear); This...
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diagnosed with DVT/slight pain in right calf/severe pain in right calf (unable to weight bear); This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 02Apr2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included retinoblastoma, menorrhagia and fibroids from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestrel (OGESTREL-28) taken for menorrhagia, uterine leiomyoma; iron taken for an unspecified indication, start and stop dates for both were not reported. On 03Apr2021, the patient woke up with slight pain in right calf. On 04Apr2021, she woke up with severe pain in right calf (unable to weight bear), then went to Urgent Care and was diagnosed with deep vein thrombosis (DVT) 7cm. Started apixaban (ELIQUIS) for 3 months, stopped low norgestrel. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering.
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| 52 | 2021-05-01 | platelet count decreased |
platelet level was low; This is a spontaneous report from a contactable consumer (patient). A 52-yea...
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platelet level was low; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 07Apr2021 12:30 (Batch/Lot Number: ER8737) (at the age of 52-years-old) as single dose for Covid-19 immunisation. The patient had no medical history and had no known allergies/ The patient was not pregnant. The patient did not have Covid prior to vaccination. Concomitant medications included minerals nos, vitamins nos (CENTRUM) and cyanocobalamin (NATURE MADE B12 VITAMIN). The patient previously received the first dose of BNT162B2 on 17Mar2021 at 12:30 PM (Lot: EN6207) (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive other vaccine in four weeks. Bruises began appearing on legs weekend (10Apr2021) following dose 2. Bruises began appearing on arms. On Wednesday, 14Apr2021, the school nurse noticed a big bruise on the patient's arm and she asked how the patient got it. The patient told her she had no idea but they were on her legs too. She (nurse) looked and told the patient to call doctor ASAP. Had bloodwork done the next morning (15Apr2021) and got call from PCP office to get to the ER because platelet level was low and the patient was a brain bleed risk. Her platelets were at 3,000 at ER. Had a platelet transfusion as well as a brain scan, lung scan and leg ultrasounds. The patient was hospitalized from April 15 to 18, 2021. The patient received 4 days of dexamethasone 40 mg daily. Her platelets were decreasing again and she was now heading to (hospital name) on 28Apr2021 for potential dose of Romisplostim. The event resulted to a visit to the doctor and emergency room. The event was assessed as life threatening and requiring hospitalization by the reporter. The patient underwent nasal swab Covid test in the hospital as protocol on 15Apr2021 with negative result. The outcome of the event was not recovered.
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| 52 | 2021-05-04 | blood pressure decreased, fainting, chest discomfort, palpitations |
allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired;...
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allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired; light headedness; Didn't feel very comfortable; weak in the legs; She was warm or cold, hot then suddenly cold; chills; fogginess; fainting reaction 15 minutes after getting the shot; palpitations for an hour; numbness in her lower jaw/bottom jaw was half numb; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/Every next breath was getting weaker and they disappeared after an hour. She felt like someone was holding her chest, do not let her to deep breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-year-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:30 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at the age of 52-years-old) as single dose for COVID-19 immunisation. She reported says she was getting it because people who were vaccinated are being less cautious and putting her at risk for COVID. The vaccination facility was organized through a pharmacy was not administered in a military facility. Medical history included measles on an unknown date (she was sick only once with measles). The patient reported no family medical history but the only thing to put about her probably was that she has maybe rare in a good way immune system. She thought children infections that kids usually get, some of them are very contagious, she was sick only once with measles. She says she has never had chicken pox, she was not vaccinated for chicken pox, she was in contact with multiple people with chicken pox, has antibodies with chicken pox but she never had symptoms, she was never sick. She said she was never sick with any children's infection, she usually did not get sick at all, no flu, no cold things, never. She was not sure if it was measles or if it was rubella as she was translating from another language. There were no concomitant medications. The patient previously took lidocaine and experienced allergy with symptoms of cold sweat and palpitations. She says this allergy started a very long time ago. She said it was affecting only dental procedures and that they know about so they just don't use it on her. She says they consider it not be the lidocaine but due to the ephedrine inside of the lidocaine. She lists her symptoms as cold sweats and palpitation, no pain. She reported they thought the reaction was just too strong, she had 2 episode in 2 different offices, they don't use it on her. The patient had no prior vaccinations within four weeks. The patient declined being sick at the time of vaccination. On 08Apr2021, the patient experienced fainting reaction 15 minutes after getting the shot , palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess. On 14Apr2021, the patient experienced blood pressure was very low at about 80/59, wasn't able to lift her hands, weak again and dizziness. The patient's second dose was supposed to be next Friday but her healthcare provider thought it was an allergic reaction (unspecified date) and advised her to not get the second dose. The patient wanted to know what would Pfizer advise. The patient did not know if it was because of COVID but thought those were the effects of any kind of vaccines. The patient clarified her jaw was only half numb. She reported the events started after 15 minutes, the jaw was later, palpitations started after she broke the pattern of her thinking, that wasn't right. She said we had the list but it was missing that it started with one symptom and was replaced by another symptom. She said the only 2 that were together was the jaw part and the palpitations. She says the jaw part was a very short period of time, she felt it and thought what was this, she did not know how long it was, maybe one minute, less than one minute. She reported her palpitations were periodical palpitations, every next breath was getting weaker and they disappeared after an hour. The patient also reported her legs part was after the palpitations were gone. She had talked to multiple nurses and she realized from telling the story 5 times that the symptoms started from up to the bottom; the reaction was from her head to her legs. She reported that she doesn't feel very comfortable, she doesn't know what will happen to her, no one knows. She says all symptoms were on the same day, she was able to move and felt comfortable to move after an hour and a half. She says she started to move after symptoms in the legs started to disappear, she was not able to take deep breath but she was able to breathe without destructions. She says she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing. She tries to explain the temperature situation, saying the feeling during this time was warm or cold, hot then suddenly cold, that there was no one explaining what happened with her. She says she she remembers noticing that suddenly she had chills. cold, she was talking to someone and she felt cold, she can't exactly say what. She says this probably lasted half a day, maybe 12 hours: She says she was very dizzy on that day, suddenly, and at night she measure her pressure to see what is going on. She says she she has been known for low blood pressure earlier in her life. She says 110/70 was her normal and she had around 80 something, 86/59, something like that, she hasn't had such a low blood pressure in 30 years, maybe since her pregnancy. She stated that she has recovered completely from everything. She says she is not sure if its coming back, she did not expect to have low blood pressure, but right now she is totally fine, a normal person. The patient confirmed her blood pressure was, she thought 86/59 on 14Apr2021. She said she took her blood pressure 2 times, a couple times, the first time was even lower on 14Apr2021. She says on the actual 08Apr2021 she took her blood pressure and it was 120 over something, a little bit higher than it usually would have been. She said she was usually running towards the lower acceptable range, 110 to 70, 110 to 75, something like at doesn't get more than 113. The events did not require a visit to emergency room nor a visit to physician's office. The patient wanted to know if these side effects were known to Pfizer and what happens to those side effects. She asked do they have information on if they increase with the second vaccine. The outcome of the events fainting reaction 15 minutes after getting the shot, palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess was recovered on 08Apr2021; outcome of events weak again, dizziness, wasn't able to lift her hands, blood pressure was low was recovered on 14Apr2021; while outcome of allergic reaction was unknown.
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| 52 | 2021-05-06 | hypertension |
24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was m...
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24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.
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| 52 | 2021-05-06 | loss of consciousness |
lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomitin...
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lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same patient/reporter, different AE/first dose.
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| 52 | 2021-05-07 | fainting, hypotension |
I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tinglin...
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I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; My blood pressure was 89; When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; pain in joint; I have been feeling burn; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 19Mar2021 08:45 (Batch/Lot Number: EN6204) and second dose via an unspecified route of administration, administered on left arm on 09Apr2021 09:15 (Lot Number: EP7533) as single dose, for covid-19 immunization. The patient Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient concomitant medications were not reported. On 20Mar2021 02:00 PM, the patient fainted after the 1st dose. Her blood pressure was 89. When she regained conscious, she started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet. Since then, she had been feeling burn and tingling in her hands and feet. Some pain in her joint. The paramedic asked her to walk and then It went away on that moment. The patient underwent lab tests and procedures which included blood pressure measurement was 89. The patient did not receive any treatment for the events. The outcome of the events was reported was recovered /Recovered with lasting effects. Information about Lot/Batch number is obtained. Additional information has been requested
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| 53 | 2021-01-03 | heart rate increased |
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, ...
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After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health
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| 53 | 2021-01-03 | lightheadedness, chest discomfort, blood pressure increased |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | palpitations |
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ...
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pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
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| 53 | 2021-01-04 | blood pressure increased |
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi...
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Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
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| 53 | 2021-01-04 | chest discomfort |
Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received firs...
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Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
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| 53 | 2021-01-04 | chest pain | Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB |
| 53 | 2021-01-04 | heart rate increased |
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ...
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Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-04 | palpitations |
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena...
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heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 53 | 2021-01-05 | blood pressure increased, heart rate increased |
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi...
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associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
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| 53 | 2021-01-06 | palpitations |
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se...
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Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
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| 53 | 2021-01-06 | chest discomfort |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-07 | fast heart rate |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% Â At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-07 | palpitations |
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s...
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neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-08 | hypotension |
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note...
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Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
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| 53 | 2021-01-08 | hypertension |
HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat ...
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HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat 100%; Pt was placed on observation. 0944- VS taken again,BP 177/89, HR 94, O2Sat 100% 1000- Pt stated she was feeling better and event was probably due to anxiety; Pt declined going to ED; VS taken again, BP 149/83, HR 85, O2Sat 100%; Pt discharged home.
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| 53 | 2021-01-10 | chest discomfort, blood pressure increased |
Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vac...
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Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vaccine dose #2. H/O Myasthenia gravis and experienced exacerbation of myasthenia gravis.
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| 53 | 2021-01-10 | blood pressure increased, chest discomfort |
Within 10 minutes of receiving COVID Vaccine dose #2, patient experience chest pressure, increased b...
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Within 10 minutes of receiving COVID Vaccine dose #2, patient experience chest pressure, increased blood pressure and exacerbation of myasthenia gravis. Patient has a history of myasthenia gravis.
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| 53 | 2021-01-10 | fast heart rate |
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno...
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Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
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| 53 | 2021-01-10 | lightheadedness, chest discomfort, heart rate increased, hypertension |
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n...
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chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 53 | 2021-01-11 | lightheadedness |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | loss of consciousness |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | oxygen saturation decreased |
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (histor...
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Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
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| 53 | 2021-01-12 | blood pressure increased, chest discomfort |
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ...
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12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
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| 53 | 2021-01-12 | heart rate increased |
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), ...
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@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
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| 53 | 2021-01-12 | fast heart rate, blood pressure increased |
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo...
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Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
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| 53 | 2021-01-12 | fainting | Systemic: Fainting-Severe |
| 53 | 2021-01-13 | body temperature decreased |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-14 | heart rate increased |
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ...
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Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 53 | 2021-01-14 | hypertension, fast heart rate |
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan...
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shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 53 | 2021-01-15 | chest discomfort |
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min...
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Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
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| 53 | 2021-01-16 | fainting, loss of consciousness |
On 01/01/21, I experienced a vaso vagal syncope episode and actually passed out and injured my upper...
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On 01/01/21, I experienced a vaso vagal syncope episode and actually passed out and injured my upper back and right side of rib cage. I am a nurse and was looking up the required reporting and saw this as a reportable event, and even though it indicates within 7 days, I thought it might be worth reporting. I have never passed out like that before.
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| 53 | 2021-01-16 | hypertension | Severe abdominal pain, nausea, high BP |
| 53 | 2021-01-16 | loss of consciousness |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-18 | chest discomfort |
Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore...
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Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore throat on 1/13/2021. Continues to have sob, chest pressure, abd pain, and fatigue. COVID test neg on 1/17.
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| 53 | 2021-01-18 | fainting |
I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I pa...
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I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I passed out, I bit my lower lip and it bled quite a bit. I had brain fog, and couldn't come up with the correct words. Also, I could not sleep that night, at all without taking a few sleeping pills. It has been a week since this happened and I still can't sleep on my own. I used to be able to go right to sleep without any sleeping pills within about 5 min after laying down at night.
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| 53 | 2021-01-18 | blood pressure increased |
Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was...
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Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was elevated. Observed in clinic and given food / gatorade. Pt recovered without incident and released.
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| 53 | 2021-01-19 | heart rate increased |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-20 | chest pain |
C/O Chest pain, fatigue, fever >100.0, the next day, post vaccination. No medical evaluation. Sx's...
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C/O Chest pain, fatigue, fever >100.0, the next day, post vaccination. No medical evaluation. Sx's resolved on their own. CG has no ongoing complaints and is currently working
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| 53 | 2021-01-21 | hypertension |
30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every...
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30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every 15 minutes for hour an normal . Prescription Anti Nausea Ondansetron 4 mg
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| 53 | 2021-01-21 | blood pressure decreased, fainting |
About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sen...
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About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sent to ER at time of admission blood pressure was going down and back to normal within hour and gave anti- nausea medicine . Blood pressure every :15 for hour 128/76 event resolve . Ondansetron 4 mg Face and chest rash 24 hours later Benadryl 25 mg
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| 53 | 2021-01-21 | hypertension |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-23 | chest discomfort |
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started...
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Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
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| 53 | 2021-01-24 | heart rate increased, blood pressure increased |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-25 | palpitations, blood pressure increased, blood pressure decreased |
Roughly 7-8 min after the vaccination, my pulse began racing. It was 152. I requested help. My bloo...
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Roughly 7-8 min after the vaccination, my pulse began racing. It was 152. I requested help. My blood pressure had also skyrocketed. EKG was ok. No swelling, no itching, no difficulty breathing. However, blood pressure was significantly higher than anything ever experienced. Hour later was still 169/92 (my norm is 110 or 120 over 70), and pulse rate still around 112-114. Not yet resolved. 9 hours later, pressure is coming down, but still 137/81 with pulse still at 99 while just sitting) usually in 70s.
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| 53 | 2021-01-26 | heart rate increased, palpitations |
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,...
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I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
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| 53 | 2021-01-26 | blood pressure increased, fast heart rate |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-27 | nosebleed, loss of consciousness |
12/23 Vaccination 1/2/2021 Woke up at 1am, stepped outside. Feeling extremely dizzy, passed out face...
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12/23 Vaccination 1/2/2021 Woke up at 1am, stepped outside. Feeling extremely dizzy, passed out faced down on the ground. Nose was bleeding. Referred to PCP
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| 53 | 2021-01-27 | hypertension |
Hypertensive and headache after vaccination and sent to ER. Has history of hypertension and takes m...
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Hypertensive and headache after vaccination and sent to ER. Has history of hypertension and takes medication or this.
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| 53 | 2021-01-27 | blood pressure increased, heart rate increased |
couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when che...
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couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when checked. (162/104 and 122 hr)
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| 53 | 2021-01-28 | loss of consciousness |
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ...
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lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-28 | chest discomfort, pallor |
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai...
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mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
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| 53 | 2021-01-28 | chest discomfort |
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh...
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she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
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| 53 | 2021-01-29 | heart flutter, cardiac arrhythmia |
Pt was seated in the 30 min waiting area. Pt states she felt her heart flutter and would like to be ...
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Pt was seated in the 30 min waiting area. Pt states she felt her heart flutter and would like to be checked out. Pt was assisted in walking to the cot. Pt laid supine on the cot. Pt was placed on 4 lead EKG. Pt's EKG showed regularly irregular PVC's. Pt's vital are normal. Pt states she does not feel as if her heart is fluttering anymore. Pt's second 4-lead EKG is normal. Pt refused transport to hospital.
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| 53 | 2021-01-30 | chest pain, palpitations, blood pressure increased, arrhythmia |
? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm nec...
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? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm neck hurting lasts 2 hours.6pm feet are burning hot to the touch. ? Jan 22, 12 am Arrhythmias, racing heart rate, uncontrollable shaking, throat is feeling sore and difficulty swallowing. I go to the ER . While waiting to see a doctor my symptoms subside. Dr. prescribes an epi-pen. Explains that they do not know about the vaccine. ? Jan 23, 3am uncontrollable shaking, neck hurting feet burning. 4am nausea, headache still continues. ? Jan 24, massive headache continues, nausea, diarrhea, I go to Urgent Care Center. They do a blood test must wait a few days for results. ? Jan 25, Massive headache continues, uncontrollable shaking ? Jan 26, 2am, headache continues, uncontrollable shaking, burning feet, blood pressure 164/103. Back to Urgent care. Add blood pressure meds. ? Jan 29, 12 am Shaking, blood pressure168/85 ? Jan 31st Sunday 7pm, Muscles tightening up in lower body, chest pain Symptoms ongoing, Doctors do not know enough about the vaccine to treat the problem.
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| 53 | 2021-01-31 | heart rate increased |
18:52 PM Pt began to feel a rapid heart beat & saw that on the side effect profile on paper. Now s...
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18:52 PM Pt began to feel a rapid heart beat & saw that on the side effect profile on paper. Now she feels the same -normal.
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| 53 | 2021-01-31 | blood pressure increased, blood pressure decreased |
Patient had elevated BP (160/92) at 8:50 am, lower (138/90) at 9:03 am, returned to normal (132/82) ...
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Patient had elevated BP (160/92) at 8:50 am, lower (138/90) at 9:03 am, returned to normal (132/82) at 9:16 am.
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| 53 | 2021-01-31 | lightheadedness |
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa...
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not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
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| 53 | 2021-02-01 | palpitations, heart rate increased, blood pressure increased |
Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was lea...
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Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was leaving the hosp. and started feeling strange and my heart was racing and I felt shaky. I went to the ER at the hospital I received my vaccine at.
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| 53 | 2021-02-01 | fibrin d dimer increased |
Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad...
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Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
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| 53 | 2021-02-02 | chest discomfort |
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spont...
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Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-03 | palpitations |
Developed palpitations with orthostatic Increase in heart rate upon standing; Developed palpitations...
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Developed palpitations with orthostatic Increase in heart rate upon standing; Developed palpitations with orthostatic Increase in heart rate upon standing; Concern for postural orthostatic tachycardia/POTs; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL0140, intramuscularly on 21Dec2020 07:30 at single dose in Left arm for COVID-19 immunization in hospital. Medical history was none, no known allergies. Patient didn't have covid prior vaccination. There were no concomitant medications. There were no other vaccines in four weeks and no other medications in two weeks. The patient developed palpitations with orthostatic increase in heart rate upon standing. Concern for postural orthostatic tachycardia/POTs. Adverse events started from 23Dec2020, 07:00 AM and resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not recovered from the events. Covid test with nasal swab type post vaccination was performed on 01Jan2021 with negative result.
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| 53 | 2021-02-04 | hypertension |
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate...
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Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
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| 53 | 2021-02-04 | palpitations |
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena...
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She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 53 | 2021-02-07 | heart rate increased |
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va...
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Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
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| 53 | 2021-02-07 | heart rate increased, palpitations |
body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159...
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body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159/110; chills; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left shoulder/deltoid left on 20Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing hypertensive diagnosed four years ago. Concomitant medications the medication that she took for her blood pressure. The patient took first dose Covid 19 vaccine two days ago. She started feeling chills on 20Jan2021 and body aches on 21Jan2021. The patient stated two days ago that she had heart palpitations that speeded up to 159/110 all day on 20Jan2021. She was a hypertensive person and her blood pressure will go up. She was told there would be risks. She wanted to know if she should take the second dose on 10Feb. Wanted to know if something will happen to her if she took it. The chills lasted only two hours. The body aches stopped at 5PM. She had heart palpitations with activity and only lasted for 24 hours. The patient had none while laying down. No treatment was received. Outcome of the event chills was recovered on 20Jan2021, of the events body aches and heart palpitations that speeded up to 159/110 was recovered on 21Jan2021. Information on the lot/batch number has been requested.
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| 53 | 2021-02-08 | heart rate increased |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-09 | heart rate increased |
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rat...
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my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
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| 53 | 2021-02-11 | heart flutter |
Injection occurred at 4:50 pm on January 28th. On February 7th I took a hot bath with magnesium sulf...
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Injection occurred at 4:50 pm on January 28th. On February 7th I took a hot bath with magnesium sulfate Epsom Salts around midnight and went to bed. A few hours later, perhaps around 3 am I started to feel like I was coming down with the flu and feeling aches. By Morning at 7:30 am I felt awful. Significant muscle pain all throughout my body which was debilitating and made it difficult to get around. Very serious joint pain as well. Also very stiff and felt difficult to walk even. Took the day off from work and took ibuprofen and slept most of the day. Was very difficult to function in the morning and felt foggy in the head too. Couldn?t get out of my pajamas and stayed mostly in bed. Symptoms for better by about 5 pm and improved throughout the night. Felt much better the next morning and went to work. However yesterday, February 11th I felt some heart flutters which seemed out of place.
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| 53 | 2021-02-11 | loss of consciousness |
PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE...
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PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE FOR 20 MINUTES POST-VACC. SHE WAS ON HER WAY HOME AT 50 MINS. POST-VAC WHEN SHE BECAME UNCONSCIOUS, UNRESPONSIVE, & PRESENTED W/HIVES. SHE WAS TREATED AT EMERG. DEPT. AFTER 90 MIN, SHE IS CONSCIOUS & IMPROVING.
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| 53 | 2021-02-11 | chest pain |
Went to hospital for shortness of breath and chest pain after 2nd shot. Nurse had advised me that pr...
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Went to hospital for shortness of breath and chest pain after 2nd shot. Nurse had advised me that previous patient had come in with same symptoms as well after vaccine. Drs found no results to cause issues
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| 53 | 2021-02-14 | loss of consciousness |
Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was giv...
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Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was given Benadryl 50mg IM. Within 15 seconds she reported not feeling well. Then she started seizing for about 30 seconds. Initial BP 148/88 and pulse ox 98. After 5 mins BP of 125/77 and pulse ox 99%. Patient regained consciousness, was A&O x3 but felt weak/tired. She was transported to the hospital.
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| 53 | 2021-02-14 | chest discomfort |
Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was havi...
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Initially, soreness around injection site. Backaches. Then the next few days, I realized, I was having a flare up of sjogrens. Dry mouth and dry eyes were worse. Dry cough, chest discomfort was the most difficult to deal with and GERD issues got worse
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| 53 | 2021-02-14 | blood pressure increased |
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak...
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Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
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| 53 | 2021-02-14 | blood pressure increased | Rash, lightheadedness, weakness and tingling, throat closing, elevated blood pressure |
| 53 | 2021-02-14 | chest discomfort, heart attack |
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl...
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reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-16 | blood pressure increased |
Since 2nd vaccine my BP has been up. Prior to vaccine it would range 107/75 to 138/85. After vacci...
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Since 2nd vaccine my BP has been up. Prior to vaccine it would range 107/75 to 138/85. After vaccine it would range 135/80 to 170/90 on same dosage of medication. I've had to double my medication to be able to keep it at a range of 128/80 to 155/85 for the past month. I thought it might be in my mind at first, but when my Mom recently got her 2nd injection, she had a stroke within 24 hrs. Her BP was very well controlled, but within 24 hrs after vaccine it was 180/110. I understand she was older etc, but I'm thinking certain genotypes may be more predispositioned for this kind of reaction and that doctors/caregivers may want to be more aware and prepare their patients for this.
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| 53 | 2021-02-17 | hypertension |
Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular...
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Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular Disease."
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| 53 | 2021-02-17 | fainting |
Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient receive...
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Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-02-21 | fainting |
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl...
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Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-02-21 | fast heart rate, palpitations |
Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, sympto...
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Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.
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| 53 | 2021-02-22 | heart rate increased |
At approximately 9:30 pm, my bpm increased dramatically. I normally have a 70 - 85 bpm and last my ...
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At approximately 9:30 pm, my bpm increased dramatically. I normally have a 70 - 85 bpm and last my my heart rate ranged from 120 - 152 while lying in bed. It still is above 100 today.
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| 53 | 2021-02-22 | troponin increased, hypertension, chest discomfort, inflammation of the heart muscle |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-22 | chest discomfort |
Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler...
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Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler. Later that evening I took my reg asthma meds. Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well. 1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.
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| 53 | 2021-02-24 | palpitations |
Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything...
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Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything smelling sweet, tingling in hands and feet, hands shaking, slight nausea. Evaluated by EMS. Had not eaten given water and tea. Ate protein bar. Feeling better, symptoms resolved. Discharged home at 9:45am.
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| 53 | 2021-02-24 | chest discomfort |
Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a...
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Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a slight cough and chest pressure. Pressure is worse with deep breathing. Denies chest pain. Denies SOB or wheezing. Pt also had episode of loose stool x 1. States she has had an anaphylactic reaction in past, but it did not feel the same. Pt took diphenhydramine 50 mg PO before receiving her vaccine after consulting her PCP. When pt presented to convenient care, vitals WNL. Pt given methylpredisolone 125 mg IM x 1. Pt prescribed epinephrine 0.3 mg injectable 2-pak kit. Provider recommended pt not receive the 2nd dose of vaccine unless PCP says otherwise. Pt discharged to home. 2/1/21: Pt continued to endorse loose stools, fatigue, and body aches. 2/2/21: Pt's PCP told her not to receive 2nd dose of vaccine.
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| 53 | 2021-02-26 | chest discomfort |
Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vacci...
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Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vaccine. Pain persisted, 911 was called. BP of 186/96, SPO2 98, HR 92. Patient sweating, appeared very anxious. EKG negative for ST elevation. Patient transported to hospital.
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| 53 | 2021-02-27 | palpitations |
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk...
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Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
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| 53 | 2021-02-28 | heart rate increased, fast heart rate, cardiac arrest |
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin...
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First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
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| 53 | 2021-03-04 | chest discomfort | Shortness of breath, chest tightness. BP 179/111, pulse 103, 97% O2 sat. |
| 53 | 2021-03-07 | palpitations |
Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling...
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Symptoms: throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling faint. This happened 10 minutes after shot was given. Benadryl shot was given in arm and didn't help and then epipen was administered. Then taken to ER and given Decadron and Pepcid. Was monitored for 4 hours and sent home.
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| 53 | 2021-03-08 | chest discomfort |
12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days....
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12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days. 16 hours after vaccine, wheezing, chest tightness and throat tightness which improved after 4 days using Benadryl and Pepcid. Visited Dr. on 2/12/2021 and was prescribed an Epi pen, oral and topical steroids.
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| 53 | 2021-03-08 | chest discomfort |
12:01PM BEGAN TO FEEL SHORTNESS OF BREATH, CHEST PRESSURE, LIGHTHEADEDNESS. AFTER RECEIVING 2ND DO...
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12:01PM BEGAN TO FEEL SHORTNESS OF BREATH, CHEST PRESSURE, LIGHTHEADEDNESS. AFTER RECEIVING 2ND DOSE OF PFIZER VACCINE LOT # EN6200.
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| 53 | 2021-03-08 | chest pain, hypertension |
FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE W...
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FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE WAS ALSO COLD AND SHAKING. BLOOD PRESSURE HIGH ( 911 WAS CALLED PT REFUSED TO GO TO THE HOSPITAL). WE KEPT HER IN OBSERVATION WITH EMS ONSITE, AFTER MORE THAN ONE HOUR SHE COMPLAINED OF CHEST PAIN, TRANSFERRED TO ER VIA AMBULANCE.
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| 53 | 2021-03-08 | chest pain |
Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hou...
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Very mild abdominal tightness within the first 15 min, no big deal and I did not report. About 4 hours later notice marked abdominal/gut tightness and bloating. Very fatigued. Swelling in extremities and moderate joint pain. Increased thirst. Next morning had sharp pleuritic type of chest pain increased with inspiration lasting about 20 min. Moderate/severe fatigue. Abd tightness, bloating, and fatigue continued for the next 48 hours and persisted but is milder today on 3/9. Continued fatigue. And the expected headache.
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| 53 | 2021-03-09 | chest pain |
Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. ...
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Throat felt scratchy gave 50mg/mL IM benadryl. Face swelled up and turned red and her chest hurt. Gave 0.3mg epipen vastus lateralis. Brought patient to ER via wheelchair
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| 53 | 2021-03-10 | heart rate increased |
1/11/2021 vaccination 28 hours later, I was sitting on the couch, and everything starting shifting t...
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1/11/2021 vaccination 28 hours later, I was sitting on the couch, and everything starting shifting to the left and spinning. Lasted a 1-2 minutes, HR increase, and became diaphoretic. Stayed in bed rest of the day; lightheadedness. I called my PCM the next day and I said is this something I need to be seen? Informed to cb if still felt this way. 2/19rd recurred episode with same symptoms. 2/22 I saw the Dr; ordered on MRI *have had a couple more episodes since; occurring on Left side.
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| 53 | 2021-03-10 | palpitations |
15 mins post vaccination of pfizer vaccine, pt stated she feel her heart beat was racing fast. Vital...
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15 mins post vaccination of pfizer vaccine, pt stated she feel her heart beat was racing fast. Vital signs checked 158/94 P 116 R 18 T97.8, O2 Sat 98% RA. Pt encouraged to relax, fluid oftered + tolerated well. vital signs rechecked 20mins later BP 146/90,P 82 R 16,T97.8, O2 sat 100% RA. Patient stated "I feel better now". As per patient and husband pt has history of Anxiety. RN encouraged patient to relax for few minutes so patient left the floor in stable condition accompanded by her husband and son. No further complain reported.
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| 53 | 2021-03-10 | chest discomfort | Mid chest felt full and loose. Felt like she was going to "pass out" but did not. Denies SOB, CP. |
| 53 | 2021-03-11 | fast heart rate | Tachycardia, resolved on own, cleared by medics. |
| 53 | 2021-03-12 | palpitations | Extreme fatigue, head ache, heart racing, dizziness. Still happening 8 days later |
| 53 | 2021-03-13 | chest pain |
Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started w...
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Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started with back and chest pain along with not being able to get a good breath in.
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| 53 | 2021-03-14 | deep vein blood clot, fibrin d dimer increased | Left femoral DVT |
| 53 | 2021-03-14 | palpitations |
Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day...
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Patient felt mouth tingling with 1st dose & red scattered rash next day. After second dose next day symptoms of body aches/joint pain, severe headache, neck back pain, fever 101. Heart palpitations.
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| 53 | 2021-03-14 | hypotension |
Started with migraine, fever, chills after three hours of injection, night two same, night three sam...
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Started with migraine, fever, chills after three hours of injection, night two same, night three same, four night histamine levels were high and developed hives on back and chest area, fever, five night same, sixth night shortness of breath, fever, seventh night shortness breath, fever. Night eight same, tenth day went to urgent care x-ray lung had fluid and pneumonia . 12 day blood pressure was 80/50 and admitted in ER.
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| 53 | 2021-03-15 | heart rate increased, blood pressure increased |
Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood ...
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Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood pressure Dry mouth and throat Dizziness
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| 53 | 2021-03-15 | heart attack, blood clot |
I received my first vaccination on February 11, 2021. On February 17th I was rushed to my local ER ...
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I received my first vaccination on February 11, 2021. On February 17th I was rushed to my local ER with a massive heart attack. I was rushed by helicopter to second hospital where I underwent an emergency Heart Catherization. It was discovered that I will need a triple bypass surgery. However, there is a HUGE blood clot that formed in my heart, and further treatment is on hold for now, until the massive clot has safely dissolved.
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| 53 | 2021-03-15 | lightheadedness | dizziness, pre-syncopal. Evaluated by EMS-Cleared |
| 53 | 2021-03-16 | cerebrovascular accident |
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collaps...
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12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
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| 53 | 2021-03-16 | heart rate increased |
Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atara...
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Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atarax, benadryl, extra strength Tylenol, Hydrochloathiazide
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| 53 | 2021-03-17 | heart rate increased |
Rapid heartbeat for 15 minutes 9 hours after the injection. Heartbeat was so rapid woke me up from ...
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Rapid heartbeat for 15 minutes 9 hours after the injection. Heartbeat was so rapid woke me up from a sound sleep. I felt like I was having a heart attack. I am a runner and a healthy individual. My heart rate has never been like that.
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| 53 | 2021-03-18 | chest pain |
Left thoracic chest "twinges" repeatedly, approximately every 5 minutes for 1-1/2 days, starting on...
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Left thoracic chest "twinges" repeatedly, approximately every 5 minutes for 1-1/2 days, starting on awakening 3/7/2021, ended around noon on 3/8/2021. No radiation, no associated symptoms. Occasional soreness, left scapular area also occurred periodically during this same time period.
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| 53 | 2021-03-19 | loss of consciousness |
On mar 18 late afternoon i started with a burning in my neck and the pain kept getting worse then it...
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On mar 18 late afternoon i started with a burning in my neck and the pain kept getting worse then it went to my head and my head started killing me. I tried to eat cuz i thought i might be hungry, i was also very confused and i ended up passing out at the food place at the table, i never ate i woke up cuz i had to puke them i ran outside and threw up a total of 4 different times from that point on for the next 3 days i couldn?t keep my eyes open i was beyond tired i had no control my eyes would close and i would fall asleep for hours at a time. It?s day March 20 and I?m still exhausted tired trying to fight the fatigue.
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| 53 | 2021-03-20 | blood pressure decreased |
At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was d...
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At 35 minutes post shot, I started experiencing lower abdominal cramping. This occurred when I was driving home and continued for an hour or 2 after shot. For about 24 hours, I had very intermittent cramping. For a couple of hours after shot, I had a metallic taste in my mouth. I also had some stiffness in my right hand and wrist appear after a few hours that was gone when I woke up the next day. I had 1 episode of loose stools the next morning. For 5 days after I felt off especially in the morning, with some slight dizziness, and something similar to restless leg syndrome which I have had some years ago. (at night.) I took my blood pressure and it was low. It remained low in the morning for 5 days.
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| 53 | 2021-03-21 | fast heart rate, heart rate increased |
Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain t...
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Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain the same, now itchy. 03/21 as with the first shot (Report: 315416), today I developed increased heart rate (I have SVT but controlled with meds), upper abdominal pain, cramping, diarrhea, bloating, inability to eat/drink without stomach pain. It took me 3 weeks to get back to almost normal but to me it appears both shots causes gastrointestinal issues or aggravates existing issues like IBS (which I have). 03/22: At the time of this submission, the heart rate is back to normal, the arm pain & swelling is not as bad but still there. The itching has gone away. The gastrointestinal issues are ongoing.
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| 53 | 2021-03-21 | fainting |
Syncopal episodes x2 after recieving injection, evaluated by medical staff and EMS, reported nausea...
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Syncopal episodes x2 after recieving injection, evaluated by medical staff and EMS, reported nausea, faint, diaphoretic, and fatigued. Vitals: HR 67, BP 126/78, 99% O2 PO Hydration was provided. Patient improved after 30min of observation and released by medical staff.
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| 53 | 2021-03-21 | haemoglobin decreased | acute autoimmune hemolytic anemia; patient had a history of PCR documented mild COVID in 4/2020 |
| 53 | 2021-03-21 | chest discomfort, palpitations | c/o dizziness, chest pressure and palpitations after vaccine administration. |
| 53 | 2021-03-21 | palpitations | slight headache productive cough stuffy nose heart palpitations trouble falling asleep/restlessness |
| 53 | 2021-03-22 | heart rate increased |
1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm,...
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1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm, flushing. PMHx: SVT, Asthma Meds: Flonase, Flovent, HRT, Levothyroxine Allergies: Sulfa Patient A & O x 4, skin pink, warm and dry, able to tolerate water well. B/P: 192/118, 173/108, 158/100 Provider on duty cleared patient to leave and instructed patient to follow up with PCP for b/p monitoring. Patient communicated understanding and was discharged home.
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| 53 | 2021-03-22 | chest discomfort |
After receiving the COVID immunization client complained of tightness in chest. She had a hard time...
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After receiving the COVID immunization client complained of tightness in chest. She had a hard time swallowing and speaking. RN asked if she could swallow Zyrtec and client shook head no. RN asked if she was OK having epinephrine injection and client shook head yes. Three minutes after epinephrine 0.3 injection in left thigh client was able to answer questions appropriately and stated she could breathe better. Vital signs were taken at beginning of client complaints and continued throughout event. EMS called and client was transported to hospital.
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| 53 | 2021-03-22 | blood clot |
Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to h...
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Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to hospital. They found a blood clot in my leg .
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| 53 | 2021-03-22 | platelet count decreased, nosebleed, low blood platelet count |
Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and ar...
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Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and arms, purpuric bruising on bottom lip, and mild nosebleeds x 2 days. Transferred on 3/11 to Hospital for lab work due to suspicion of idiopathic thrombocytopenic purpura, and found to have a platelet count <2. Treated with IVIG from 3/11 to 3/12. Platelets normalized by follow-up testing on 3/18, confirming the diagnosis of ITP.
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| 53 | 2021-03-24 | fainting | Anxiety, syncope, abnormal feeling in her throat |
| 53 | 2021-03-24 | chest discomfort |
Headache, body aches, nausea, diarrhea, cough, runny nose, extreme fatigue, swollen/sore throat, tig...
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Headache, body aches, nausea, diarrhea, cough, runny nose, extreme fatigue, swollen/sore throat, tightness in chest. Began 3/20/21 PM and progressively got worse. Doctor e-visit 3/23/21.
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| 53 | 2021-03-24 | chest discomfort |
Heavy chest/tightness, wheezing, not able to walk far, exhausted from walking and wheezing. Used my ...
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Heavy chest/tightness, wheezing, not able to walk far, exhausted from walking and wheezing. Used my inhaler every two hours and no relief. Kept getting worse. Tried Mucinex liquid Severe Chest Congestion and Sudafed.
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| 53 | 2021-03-24 | chest discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle...
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Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia. 48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
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| 53 | 2021-03-25 | platelet count decreased, haemoglobin decreased | Easy bruising, petechiae, gum bleeding, aches and joint pains |
| 53 | 2021-03-25 | platelet count decreased |
I had my vaccine on Saturday and on Monday my platlets were at 16. I was almost hospitalized but, af...
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I had my vaccine on Saturday and on Monday my platlets were at 16. I was almost hospitalized but, after steroids they improved.
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| 53 | 2021-03-25 | hypertension |
Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to am...
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Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to ambulance. no resp. distress noted. no wheezing noted. vital 164/84, 84, 16,100 % RA blood sugar 121 Patient refused transport.
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| 53 | 2021-03-25 | heart rate increased |
Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he ...
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Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he told me to make sure that I'm limiting caffeine. I noticed that it's still happening off and on, so he's ordering a Holter Monitor. Currently waiting for approval to have it done.
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| 53 | 2021-03-25 | chest pain, heart rate increased |
Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in...
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Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 53 | 2021-03-25 | heart rate decreased |
Starting at 4:00 am, I had numerous instances of a HR below 40 BPM recorded on my Watch as noted: 3/...
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Starting at 4:00 am, I had numerous instances of a HR below 40 BPM recorded on my Watch as noted: 3/15/2021 - 3 instances between 4:00 am and 5:35 am; 3/17/2021 - 1 instance at 2:15 am; 3/18/2021 - 1 instance at 4:00 am; 3/19/2021 - 2 instances between 5:40 am and 6:25 am; 3/20/2021 - 4 instances between 4:11 am and 11:28 am; 3/21/2021 - 2 instances between 6:45 am and 2:48 pm; 3/22/2021 - 1 instance at 6:20 am. No further incidents as of today. No treatment.
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| 53 | 2021-03-26 | heart rate increased |
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ...
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03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
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| 53 | 2021-03-26 | loss of consciousness |
After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the e...
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After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the episode, arm wasn?t sore either.
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| 53 | 2021-03-26 | oxygen saturation decreased, heart rate increased |
My heart rate went high at resting and my oxygen went low for about 2 hours. It took 2 hours to come...
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My heart rate went high at resting and my oxygen went low for about 2 hours. It took 2 hours to come back down. My oxygen saturation was 92 and my heart rate was 159.
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| 53 | 2021-03-26 | heart rate increased, hypertension | Patient experienced stomach cramps/pain, anxiety, increased pulse/high blood pressure |
| 53 | 2021-03-30 | hypotension |
COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; sho...
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COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; shortness of breath; blood pressure of 80/50; pneumonia; fever; chills; migraine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205, expiry date: unknown), via an unspecified route of administration in the right arm, on 26Feb2021 14:30, as single dose, for covid-19 immunization, at a health department. Medical history included known allergies to latex and egg whites. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. On 26Feb2021 at 17:00, 3 hours after the vaccine, the patient experienced fever, chills and migraine which went on for 4 nights (as reported). On 03Mar2021 (reported as "fifth night"), the patient started to have high levels of histamine, hives on her back and chest and shortness of breath for three days (as reported). In Mar2021 (reported as "by the weekend"), the patient went to urgent care, underwent x-ray of chest, and had pneumonia. In Mar2021 (reported as "Monday"), the patient came back with blood pressure of 80/50 and was sent to the emergency room (ER). It was reported that the events pneumonia, fever, chills, migraine, high levels of histamine, hives on back and chest, shortness of breath and blood pressure of 80/50 required physician office and emergency room visits; treatment for these events included fluids, potassium and antibiotics (unspecified). On 06Mar2021, the patient underwent COVID nasal swab which resulted to positive. The patient recovered from events fever, chills and migraine on 02Mar2021; and from high levels of histamine, hives on her back and chest and shortness of breath on 06Mar2021. The outcome of the events pneumonia, "blood pressure of 80/50" and "COVID-19 confirmed by positive COVID-19 test" was unknown.
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| 53 | 2021-04-05 | vaginal haemorrhage, haemoglobin decreased |
I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having h...
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I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having heavy vaginal bleeding and severe stomach cramps. These continued for 9 days and then I went to the Emergency department because I felt like my HGB was low. They checked it and it was 11.3 and did an abd US that showed my endometrium was thick. They recommended follow up with GYN and a biopsy. I continued to have significant bleeding and cramps until the next week when I called the nurse line and they set me up with a virtual visit with GYN provider. She started me on progesterone and scheduled a hysteroscopy and D & C for the following week. The progesterone slowed the bleeding down but I continued to experience abd cramps. I had the D & C and after getting home started to have heavy bleeding and bad cramps again. The following week I called the GYN provider and she had me come in for another Abd US and checked my HGB which was 9.3. She also checked for infection and other labs which were all within nml range. The pathology from my D & C was neg and the GYN really was not worried that is was anything other than a period but was surprised that it was lasting so long. She gave me TXA and after 5 days on that the bleeding has now stopped but I am still having bad cramps in my lower abd and a lot of bloating. Also having lots of jolting pains in lower abd. I have never had periods that were anything like this and never really had bad cramps like this before.
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| 53 | 2021-04-08 | pulmonary embolism, fibrin d dimer increased |
53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfiz...
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53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfizer BioNTech vaccine on March 20. She tolerated the vaccine without report of systemic adverse events including headache, fevers, chills, myalgia, malaise or nausea. Eight days later (March 28) she experienced light-headedness and uneasiness reminiscent of her prior PE prompting her to visit the emergency room. Per patient D-Dimer was extremely elevated and PE protocol CT chest with IV contrast diagnosed multiple pulmonary emboli. This time, no immediate precipitating factors were identified. She has normal BMI (23), exercises regularly, is a never-smoker. She was placed on therapeutic lovenox 80mg BID. She indicated that is undergoing a workup for a hypercoagulable state and was told she may have antiphospholipid antibody syndrome, although the data and records to support this evaluation are not available for confirmation by undersigned.
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| 53 | 2021-04-09 | chest discomfort |
Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache;...
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Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-04-11 | increased heart rate |
Painless paresthesia glove and stocking distribution. Developed into painful paresthesia that persis...
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Painless paresthesia glove and stocking distribution. Developed into painful paresthesia that persists to current (4/12/2021). Intermittent sinus tachycardia and flushing. Diagnosed with autonomic dysfunction.
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| 53 | 2021-04-11 | chest pain |
Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minut...
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Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minutes had horrible lung on burning clenched up fire, gasping and coughing for breath, hives all over me reaction.
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| 53 | 2021-04-12 | pallor, hypertension |
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/...
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Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
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| 53 | 2021-04-15 | chest discomfort |
205/94, HR 70, Resp. 70, Chest discomfort, anxious, anxiety. Pt. complain of chest discomfort after ...
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205/94, HR 70, Resp. 70, Chest discomfort, anxious, anxiety. Pt. complain of chest discomfort after receiving second dose of vaccine. Emergency personnel. Pt. was transferred to Hospital for further evaluation.
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| 53 | 2021-04-15 | pulmonary embolism, chest pain |
After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021...
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After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021. Complaints consisted of chest pain, SOB, left shoulder and left breast soreness and pain, difficulty sleeping. CT and EKG test ordered and performed. - CT result showed bilateral Pulmonary Embolism. - Lower extremity doppler ultrasound was also performed and negative. Patient is still admitted to hospital and awaiting overall outcome.
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| 53 | 2021-04-15 | loss of consciousness, platelet count decreased |
received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and direct...
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received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and directed to our monitoring area. About 8:40am the clinic RN, went to assess the patient as she began to feel nauseated, began dry heaving without vomiting, had generalized redness, then complained of feeling light headed. She passed out so the RN eased her to the floor. A Rapid Response(RR) was called and the patient was moved to the stretcher. VS were taken and at about 8:50am the RR team arrived and assumed care. Once they arrived the patient began to seize. She was taken to the ER where she had another seizure. She remained in a post-ictal state for most of her stay at our facility.
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| 53 | 2021-04-16 | cardiac failure congestive | Acute Respiratory Failure/CHF Exacerbation Inability to Walk Dis-coordination of Gait |
| 53 | 2021-04-16 | pulmonary embolism, deep vein blood clot | Acute pulmonary embolism Right LE DVT |
| 53 | 2021-04-17 | loss of consciousness |
passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contacta...
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passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering. Follow-up attempts are needed. Information on lot/Batch number was obtained.
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| 53 | 2021-04-17 | heart attack |
the contractions and cramping sensation went trough out her entire chest region and her back (like h...
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the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown. Information on the Lot/Batch number has been requested
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| 53 | 2021-04-18 | low platelet count, platelet count decreased |
53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose o...
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53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose of COVID-19 vaccine 04/08/2021. 10 minutes after vaccination she started feeling nauseated and then doesn't remember what happened next. Was transported "unresponsive" to ER. CT MRI negative. Upon lab exam it was noted that her platelets had dropped from 245K to 86K. Received dose of epinephrine/solumedrol, pepcid. Diagnosed with having a seizure and thrombocytopenia. The next day her platelets had recovered to normal. Patient recovered and was discharged.
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| 53 | 2021-04-18 | transient ischaemic attack |
At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximat...
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At 6:45am on March 16, I felt my right eye cross inward. I experienced double vision for approximately 5-8 minutes. I checked my blood pressure, which was 158/89. After about 10 minutes, my vision returned to normal. I immediately went to the emergency department and was admitted. I was diagnosed with a TIA.
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| 53 | 2021-04-18 | loss of consciousness |
Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and...
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Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
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| 53 | 2021-04-19 | blood clot | Blood clots developed in leg following week on Thursday. Went for treatment Monday. |
| 53 | 2021-04-19 | cerebrovascular accident |
Stroke from a blood clot that went to the left side of my brain causing the right side of my body to...
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Stroke from a blood clot that went to the left side of my brain causing the right side of my body to be numb , weak and to lose a range of motion. Event date: 3/24/2021; hospitalized 3/24/21, 3/25/21, and 3/26/21.
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| 53 | 2021-04-21 | chest discomfort | Shortness of breath. Chest tightness. Epi given. Albuterol |
| 53 | 2021-04-24 | palpitations |
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout...
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Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
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| 53 | 2021-04-24 | loss of consciousness |
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr...
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rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
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| 53 | 2021-04-24 | inflammation of the pericardium |
she began to feel like she was straining to take a deep breath. When she would take a deep breath (l...
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she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events. The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events. Follow-up attempts are completed. No further information is expected.
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| 53 | 2021-04-26 | lightheadedness, heart rate decreased, chest discomfort, blood pressure decreased, oxygen saturation decreased |
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her...
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This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
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| 53 | 2021-04-26 | loss of consciousness, fainting |
pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consu...
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pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient (Non-pregnant) received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number ER8729 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 09Apr2021 03:00 PM, for Covid-19 immunization. Medical history included Hypothyroid, She had known allergies to Anti-Inflammatory, aspirin, penicillin, codein, ginger and horse radish. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EP7534 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 19Mar2021 04:00 PM, for Covid-19 immunization. On 10Apr2021 at 03:00 am, she woke to go to the bathroom feeling fine, after getting up from the toilet she saw stars and felt and had a Vasovagal syncope. When she woke up, she tried to get and pass out again. She woke up and was able to walk to my bed and passed out again when she reached the bed. She did not receive treatment for the events. She did not have any other vaccine in four weeks prior to suspect. She did not have Covid prior vaccination nor was she tested for Covid post vaccination. The patient had recovered from the events of pass out, vasovagal syncope and passed out again. No further information was available.
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| 53 | 2021-04-28 | cardiac arrest |
cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; s...
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cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; she had no pulse; on the ground turning purple and lifeless; This is a spontaneous report received from a contactable consumer. A 53-year-old female patient (reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), administered in left arm on 24Feb2021 (at the age of 53-year-old) at single dose for COVID-19 immunisation. The vaccination facility type was reported as other. The patient was not pregnant. The patient's medical history was reported as none. No known allergies were reported. The patient had not had COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks. It was reported that on 13Mar2021 08:15 exactly 17 days after reporter's mother received her first Pfizer vaccine she had a cardiac arrest, luckily reporter was with her when this happened and he/she called immediately and followed the steps of cardiopulmonary resuscitation (CPR) etc. When the emergency team arrived she had no pulse and they used the defibrillator on her 4 times. The entire day they did not know if she would survive. She was sedated and tested, they got the news that she had survived and there was not brain damage. The doctors had no clue what the cardiac arrest was caused by, she had no prior health conditions and the tests show nothing to what could have caused this event (no blood clots, no clogged arteries etc.). The only thing that changed leading up to the event was her receiving her first vaccine. Luckily reporter was there when this happened or else she would in fact be dead. She now had a defibrillator implanted and reporter had a post-traumatic stress from the traumatic event and witnessing his/her mom on the ground turning purple and lifeless. They need answers. The events resulted in emergency room/department or urgent care. The events were reported as serious since resulted in hospitalization and life-threatening illness (immediate risk of death from the event). Treatments were received for the events and they were reported as multiple lifesaving treatments, tests, and defibrillator implant. The patient underwent lab tests and procedure which included COVID test (negative) on unspecified date post vaccination. The outcome of the events was resolved for the event "she had no pulse" and resolved with sequel (reported as recovered with lasting effects) for all other events.
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| 53 | 2021-04-30 | blood clot |
big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand;...
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big knot there and now its black and blue and it's also like ball/could be a blood clot on her hand; Headache; sickness; felt like little vomit; not having a very good appetite; feeling like sinusy; feeling little nauseas; bruise on the top of her hand and then that bruise move to left part of her upper hand; This is a spontaneous report from a contactable consumer (patient) reported that a 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration on 08Apr2021 (at the age of 53-years-old) as a single dose for covid-19 immunisation. The patient medical history included cardiovascular disease. She has had open heart surgery, a double bypass when she was 44. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (at the age of 53-years-old) for covid-19 immunisation, and experienced face got swollen and got red and she think she got wet nose right there swelling a little bit same time her face swollen. Additional medical history included anxiety and depression. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; atorvastatin; midodrine; metoprolol; clopidogrel; ranolazine; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; colecalciferol (VITAMIN D [COLECALCIFEROL]); and paracetamol (ACETAMINOPHEN); all were taken for an unspecified indication, start and stop date were not reported. Additional concomitant medications included duloxetine taken for depression and anxiety; and alprazolam (XANAX) taken for anxiety; both start and stop date were not reported. On 13Apr2021 5 days after the second vaccination, the patient experienced headache every single day with sickness and felt like little vomit and not having a very good appetite at all. She was feeling "sinusy" but she don't have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise move to left part of her upper hand and gotten a big knot there and now its black and blue and it's also like ball; her husband and she think that could be a blood clot on her hand. The outcome of the events was unknown.
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| 53 | 2021-04-30 | blood clot |
swollen joints; her back condition and may have "pinched a nerve or something; describes it as the w...
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swollen joints; her back condition and may have "pinched a nerve or something; describes it as the worst pain; the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot; leg pain; also has some tingling on the skin; It feels like a Charley's horse; had a horrible flu; Her every muscles and every joint hurt, and her head hurt; Fever; body aches; chills; joint pain; Her every muscles and every joint hurt, and her head hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Batch/Lot number was not unknown; Expiration Date: 31Jul2021), at age of 53 year-old, as 0.3 mL single, for Covid-19 immunisation. Medical history included liver disease from 2016 and ongoing. There were no concomitant medications. The patient previously took the first dose on 17Mar2021 for Covid-19 immunization and experienced fever. The patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports having side effects after. She is specifically worried about the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot and if she needs to be worried about it. She stated that with the "swollen joints" and everything from the vaccine, it is possible that it worsened her back condition and may have "pinched a nerve or something." She describes it as the worst pain she's ever felt in her life and states it "comes out of the blue" so she does not have time to prepare for it. She likens it to a "Charley horse" but a "really bad one" that goes away and has no pain afterwards. She states she is scheduled for an MRI next week of her lower back to investigate. The patient also mentions that she thinks she had COVID-19 at the time of her vaccine because "when I got the shot, I had a super strong response." On 07Apr2021, the patient had body aches, chills, she was on the couch for quite a while. The joint pain was incredible, even in her toes. She felt like she had a horrible flu. Her every muscles and every joint hurt, and her head hurt. She was on the couch for like 4 days. On day 3 or 4 she developed intermittent pain in the leg and shin on 08Apr2021. It feels like someone is drilling a jackhammer in it. It feels like a Charley's horse, but not, more like it's in the bone. She didn't associate it with the vaccine at first, even though she had never had this pain before until she got the vaccine. She said that she has had some back problems and scheduled a MRI to see if she had pinched nerve or something. On 08Apr2021, she also has some tingling on the skin. She read about side effects of blood clots and doesn't know if this leg pain could be related to a blood clot. She assumed it could be from her back. She read that with blood clots there is usually an ache and discoloration, which she does not have now. She also read that intermittent Charley's horse could have something to do with blood clots. She has pins and needles on the skin. She also had a headache after the vaccine, but she does not have it now. She said that the pain in her leg that shoots on and bangs in her tibia hurts when bending over, lifting her leg to her chest, squatting to pick up something, and going up and down the stairs. She said that the pain is horrible and it is worse than leg pain, it is worse than a charley horse, it is the worst pain she has ever felt in her life. She cannot stop screaming when it happens. States with the joint pain that she had, there may be a nerve that's being pressed on her back. She said that with all of the information being reported in the news about blood clots, she asked is that something she needs to be concerned about. She said that she did a virtual visit with her doctor and notified her of the leg pain and asked the doctor to schedule her for an MRI because of the pain. She stated her hemoglobin and hematocrit, MCV are high. She also said that the clotting is affecting her red blood cells. She ran a fever with the first vaccine, but she had a high fever between 103-104 degrees Fahrenheit after the second vaccine that stopped on 12Apr2021 or 13Apr2021. Her high fever lasted for about 3 days. She had a low grade fever that lasted for about a week. Her body aches resolved completely on 12Apr2021 or 13Apr2021. Her joint pain is in her back and elbows. She also had lot of joint pain in her shoulder and arm and radiates to her neck on the left side. She still has some muscle pain in her leg, but overall her muscle pain is gone. For treatment she used Ibuprofen 600 mg by mouth and fluids. The day before her shot, her son called and told her he tested positive for covid. She got a PCR test immediately on 07Apr2021 and the next day she was told it was negative. She thinks she might have tested too soon. She also says her response to it was so strong, she must have been getting covid and didn't know it. She might have tested negative because she had the first shot already. She wasn't worried about exposing others and went to get her second shot, but she got really sick after that and it kicked her butt pretty hard. The outcome of the events for leg pain and tingling on skin was not recovered, fever, body aches and headache recovered in Apr2021, chills on 11Apr2021, muscle hurt/pain on 12Apr2011, joint pain was recovering, and outcome of other events was unknown.
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| 53 | 2021-05-03 | cerebrovascular accident |
I had a stroke. The blood clot is on the left side of the brain which has affected the right side of...
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I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; This is a spontaneous report from a contactable consumer. A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose (at the age of 53 years old) for COVID-19 immunisation. Medical history included depression, pre-diabetes and hysterectomy from 2003 hormones due to hysterectomy in 2003. Concomitant medications included metformin, semaglutide (OZEMPIC), estradiol, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lisdexamfetamine mesilate (VYVANSE) and ascorbic acid (C [ASCORBIC ACID]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (lot number=EL9262) at 20Jan2021 03:00 AM, on the right arm for COVID-19 immunisation. The patient stated on 24Mar2021, "I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face." Patient received blood thinners as treatment. The patient had emergency and physician visit. The patient was hospitalized for 2 days. The outcome of the event was not recovered.
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| 53 | 2021-05-04 | chest pain |
the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. ...
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the right arm is roughly 2" bigger than the left arm around it.; inflamed; Thought it was dry skin. That area is prone to dry skin.; pretty tired; shortness of breath; chest pain; rash/rash around right arm; Redness in right arm at mastectomy site, and warm to touch; Welts; red bumps; Itching; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left deltoid on 19Apr2021 14:30 at single dose for COVID-19 immunisation. Medical history bipolar disorder, breast cancer, and slightly high blood pressure. Patient had a right mastectomy and had lymph nodes removed from the right side. In the spring, when everyone was mowing grass and it was real humid outside, she got welts on her body. It was temporary and went away. Patient would get really itchy. Concomitant medications included letrozole for breast cancer (the tumor in her breast was powered by hormones. This drug suppressed hormones) from 2017 and ongoing, omeprazole for constant heartburn from an unspecified date and ongoing, propranolol hydrochloride (PROPANOLOL) for anxiety from 2016 and ongoing, clonazepam for anxiety from 2016 and ongoing, and venlafaxine hydrochloride (EFFEXOR) for bipolar disorder from an unspecified start date and ongoing. Patient previously received the first dose of BNT162B2 in left deltoid on 29Mar2021 11:30 for COVID-19 immunisation and was really tired after the first vaccine. When she was a kid, her doctor put her on steroids. Never happened after age 12. Patient also got the influenza vaccine (flu shot) a couple of years before. The patient experienced redness in right arm at mastectomy site, and warm to touch, welts, red bumps, itching, and nauseated on 20Apr2021. Patient had a right mastectomy and had lymph nodes removed from the right side. In the area where that occurred, it had become red, inflamed, and a little welty. Not all of the welts were raised, they look like they were in the skin. There was redness and it was like someone scratched her and was kind of itchy. She took 2 diphenhydramine hydrochloride (BENADRYL). Patient was very sensitive to allergies, but was not allergic to anything. Sometimes she broke out in welts in the spring. Patient got the injection in the left side but the reaction was occurring in the right side. Patient was pretty tired, but she was concerned about the rash. Patient was concerned that the right arm was roughly 2" bigger than the left arm around it. Patient had been measuring the circumference, because nurses were paranoid about things like that. It was usually not 2" more around. Patient woke up this around 10:00 am. Around roughly 12:20 pm, or probably 10 after 12, she looked in the mirror and said there it was. She noticed the itching and thought it was dry skin. That area was prone to dry skin. The welty points of redness that were raised. It looked like someone had scratched across the area. It was red, and might be the end of one red scratchy area might be a bump. It looked like, if were to put hand where the nipple used to be and open up the area. That would all be covered. It included the upper arm and the inside of the shoulder, like the front side of the shoulder. It was raised and welty redness. Not all areas were raised and was bumpy. It was all pretty red and warm to the touch. The itchiness started more after she saw it, which was terrible. Patient took diphenhydramine hydrochloride because she was concerned about an allergic reaction. She also had scheduled medications that she took in the morning. Patient took 50 mg diphenhydramine hydrochloride this morning. Patient took at 12:10 pm when noticed these things. At first, she didn't think anything, she didn't think like it was the Pfizer shot or anything. It was just a normal day. Diphenhydramine hydrochloride had done nothing for the welts yet. Patient then felt kind of nauseated. It started when we first got on the phone. She couldn't put her finger on it. Patient went to the emergency room last Monday. The incident had nothing to do with any vaccine. She had chest pain and shortness of breath. They drew all of the labs. If she wanted to know if anything in the labs was different from then and now, she could. Everything was normal. She got an inhaler. They though it might be related to all of her allergies. The only way she would go see a doctor, is if she saw that the arm was getting much bigger, like it grew 2" more. If she had a hard time breathing, she would call 911. Patient had rash around right arm on 20Apr2021, in area of past breast mastectomy. Patient first noticed itching and the redness around 12:20 pm on 20Apr2021. Had gotten progressively worse. Patient did not see in the emergency department and was not hospitalized. Patient was not admitted to an Intensive Care Unit. Multiorgan were involved. Patient just noticed new area that formed. There were lines coming out of the area and came below the sleeve line. The red rash was spreading. It looked like something invisible scratched it. There was a triangle of three dots with a little scratch mark below the sleeve. There was another dot area on the forearm that itches, just like the other stuff did. Stomach had been feeling a little jumpy. Patient had already eaten breakfast. It was not horrible. Patient would watch it and drink ginger ale. Patient was asking what parameters should be for calling 911. She was home alone. This was not life threatening but if it turned into something bigger or if she noticed getting a bigger rash, she might have to call 911. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 53 | 2021-05-10 | heart rate irregular, heart rate increased, fainting |
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremo...
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swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 53 | 2021-05-12 | deep vein blood clot |
DVT in right calf; This is a spontaneous report from a contactable pharmacist (patient). A non-pregn...
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DVT in right calf; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 53-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left arm on 21Apr2021 14:30 (Lot Number: EWO170) as 1st dose, single for covid-19 immunization. Medical history included hypertonic bladder. The patient's concomitant medication included unspecified medication. The patient experienced DVT in right calf on 26Apr2021. The event resulted in Emergency room/department or urgent care. The patient received the Xarelto 15mg as treatment. The patient was not pregnant at time of vaccination. The outcome of the event was recovering.; Sender's Comments: The event DVT was considered related to suspect drug BNT162B2 based on compatible temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2020-12-31 | hypotension |
Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest...
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Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest BP 85/60, with symptoms: lightheaded at rest.
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| 54 | 2021-01-03 | blood pressure increased |
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo...
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12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
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| 54 | 2021-01-04 | chest discomfort |
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ...
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About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
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| 54 | 2021-01-04 | blood pressure increased |
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided...
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Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
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| 54 | 2021-01-04 | heart rate increased |
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh...
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she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
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| 54 | 2021-01-05 | chest discomfort |
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel...
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20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
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| 54 | 2021-01-05 | heart rate increased |
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he...
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About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
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| 54 | 2021-01-05 | chest pain | LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED |
| 54 | 2021-01-06 | chest discomfort |
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took ...
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Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
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| 54 | 2021-01-06 | fast heart rate, palpitations |
Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, l...
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Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.
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| 54 | 2021-01-06 | blood pressure increased |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-07 | palpitations |
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ...
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About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
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| 54 | 2021-01-07 | palpitations |
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati...
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At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
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| 54 | 2021-01-07 | fast heart rate |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-1...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
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| 54 | 2021-01-07 | palpitations, blood pressure increased |
Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was ...
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Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was racing. Her blood pressure was taken in the observation area, and it was elevated. She was monitored in the observation area, and then she was escorted to the Emergency Department for continued observation. Reaction resolved with no treatment while she was in the Emergency Department and she was discharged. She was instructed to follow up with her allergist.
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| 54 | 2021-01-07 | chest discomfort, fast heart rate |
first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day,...
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first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day, felt lungs were burning and chest heaviness, tachycardia ~ 90's (today) went to an urgent care at work place tonight, lungs clear
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| 54 | 2021-01-09 | chest pain, blood pressure increased |
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l...
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Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
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| 54 | 2021-01-10 | blood pressure decreased |
"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40...
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"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
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| 54 | 2021-01-10 | loss of consciousness, palpitations |
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and...
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30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
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| 54 | 2021-01-10 | chest pain |
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri...
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Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
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| 54 | 2021-01-10 | chest pain | Shortness of breath, Fatigue, muscle aches, chest pain, dizzy and light headed, headache |
| 54 | 2021-01-10 | cardio-respiratory arrest |
Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 ...
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Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Patient was given CPR and "brought back". Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear.
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| 54 | 2021-01-10 | palpitations |
Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check an...
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Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.
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| 54 | 2021-01-11 | pallor, heart rate increased |
9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were t...
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9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were taken with BP being 183/113, HR 103 and respirations 22. Pt was sat down, given cool water and apple juice. She reported having not eaten much for the day. Her symptoms began to subside within 10 min and she required no further intervention. She was observed for a total of about 1 hr post injection . Her BP was 136/ 98, HR 83 and respirations 17 when she left for home with her husband.
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| 54 | 2021-01-11 | blood pressure increased |
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren...
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Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
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| 54 | 2021-01-12 | loss of consciousness |
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of ...
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14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor. Had slight stomach upset and significant chills. Took Tylenol and was recovered by 8 a.m.
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| 54 | 2021-01-12 | chest discomfort |
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was ...
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I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU & COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
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| 54 | 2021-01-13 | chest discomfort |
About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness...
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About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness. She then felt like she had postnasal drip and her throat began to feel like it was closing. She was short of breath until Epi pen was administered. She did not notice any swelling.
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| 54 | 2021-01-13 | fainting |
Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use t...
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Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use the bathroom and get dressed but felt nauseous with headache. Went to wash my hands and then walked back to bedroom but had syncopal episode along the way lacerating my lower lip and injuring my knees. Still unable to extend knee due to injury with pain and swelling
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| 54 | 2021-01-13 | heart rate increased, chest pain |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-14 | chest discomfort, palpitations, fast heart rate, cardiac arrhythmia |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-14 | blood pressure increased |
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ...
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Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
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| 54 | 2021-01-14 | fast heart rate | Hives within 2 hours and then onset of Tachycardia lasting 36 hours on and off. |
| 54 | 2021-01-14 | blood glucose increased |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | blood glucose increased |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-14 | blood pressure increased, palpitations |
Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccin...
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Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccine.
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| 54 | 2021-01-14 | blood pressure increased |
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (oth...
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Increase in BP to 184/91; symptoms lasted 1 day
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| 54 | 2021-01-14 | fainting |
Syncope. Rested and recovered. Fainted about 5 minutes after receiving the vaccine- walked quickly...
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Syncope. Rested and recovered. Fainted about 5 minutes after receiving the vaccine- walked quickly from the vaccination station to the observation station, and was seen wobbling, caught her and laid her until she recovered. She was embarrassed, indicated she has fainted with shots before.
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| 54 | 2021-01-15 | chest discomfort |
At approximately 20 min following dose administration noted left neck pain subsequently developed pe...
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At approximately 20 min following dose administration noted left neck pain subsequently developed perioral paresthesia, chest tightness. No stridor, drooling, wheezing or nausea/vomiting. Vitals were stable. Patient states that she took Claritin prior to her vaccination. No medications since symptoms started. States symptoms have improved in all told lasted approximately 30 min.
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| 54 | 2021-01-15 | palpitations | Dizziness and Palpitations within 15 minutes of vaccine administration |
| 54 | 2021-01-16 | fainting |
Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no r...
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Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no real nausea. Vertigo still present but now minimal. That same night I had a mild fever, but I am not concerned by this. Had some mild vertigo after the first vaccination (lot EH9899) but it only lasted 48 hrs.
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| 54 | 2021-01-17 | pallor |
Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulati...
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Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95. Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities. leg signifiant more populated than arms. Rash now on tops and bottoms of feet. Minimal spots on dorsal hands and none on palms. Extremely itchy. + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed. Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
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| 54 | 2021-01-17 | chest discomfort | c/o chest tightness, SOB, anxiety |
| 54 | 2021-01-18 | hypertension, fast heart rate |
2 min. after vax with dizzyness, mild tachycardia and hypertension. Taken to ED. Observed x 2 hours...
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2 min. after vax with dizzyness, mild tachycardia and hypertension. Taken to ED. Observed x 2 hours, improved, D/C.
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| 54 | 2021-01-18 | palpitations |
Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2...
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Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2 along with rapid heart beat, increased body aches, pounding heart and sweating. Symptoms lessoned in the morning. Fever returned the next evening (Friday 1/15). Cleared by Saturday except for tiredness. Entire episode completed by Saturday morning 1/16/21. No hospitalization or MD visit. Would have visited my Primary MD, but they referred me to the organization administering the vaccine. Vaccine was given out at work, there isn't a medical clinic available for employees.
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| 54 | 2021-01-18 | heart rate increased | Flushed, elevated heart rate |
| 54 | 2021-01-19 | chest discomfort |
Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored fo...
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Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored for 15 minutes and check vitals again. Vital signs within normal limits. Patient stated warmth in chest completely resolved. Patient monitored for 30 minutes total, the discharged to home.
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| 54 | 2021-01-19 | palpitations, chest pain, fast heart rate |
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ...
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Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
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| 54 | 2021-01-19 | chest discomfort, palpitations |
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of b...
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Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
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| 54 | 2021-01-20 | palpitations |
2nd dose PFizer EL 3246, dizzy, high temp, severe chills uncontrollable for 2 hours, body aches, he...
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2nd dose PFizer EL 3246, dizzy, high temp, severe chills uncontrollable for 2 hours, body aches, heart palpitations. called dr tierney, she told me to get covid test. I feel better 24 hours later but still have body aches and very lethargic.
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| 54 | 2021-01-20 | palpitations |
After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dos...
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After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dose) After second shot developed shortness of breath and nausea. Particularly bad with having to don mask. Did not go to ER or doctor. Has resolved somewhat' but still not able to tolerate mask.
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| 54 | 2021-01-20 | blood pressure increased |
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie...
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Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
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| 54 | 2021-01-20 | chest discomfort | chest tightness, chills, low grade fever, bodyaches |
| 54 | 2021-01-21 | chest discomfort | Tightness in throat and chest. Approx 8 hours after vaccine malaise, muscle aches, fever, headache |
| 54 | 2021-01-22 | fast heart rate, hypertension |
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45...
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Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist. A few minutes later experienced tachycardia. A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon. BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
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| 54 | 2021-01-24 | chest discomfort, loss of consciousness |
Pt reported "tightness" in chest and stumbled then collapsed on stairs near exit. Pt was beginning ...
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Pt reported "tightness" in chest and stumbled then collapsed on stairs near exit. Pt was beginning to lose consciousness. RN administered two doses of 0.3mg EPI Pen three minutes apart. Pt became more alert and reported improvement in respiratory status. EMS transported patient to hospital.
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| 54 | 2021-01-25 | chest discomfort |
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo...
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After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
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| 54 | 2021-01-25 | pallor, heart rate increased |
heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54...
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heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) intramuscular in the left arm on 12Jan2021 15:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included hypertension, asthma, hysterectomy and tumor debulking (reported as on 21Dec2021). The patient was not pregnant. Concomitant medications included hydrochlorothiazide, asthma medication and antibiotic; all from unspecified date for unspecified indication. The patient previously took erythromycin and experienced allergies. On 12Jan2021 15:45 (also reported as approximately 9 minutes post injection), the patient reported feeling her heart rate increased, was pale and diaphoretic. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events heart rate increased, pale and diaphoretic was recovered on Jan2021.
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| 54 | 2021-01-26 | heart rate increased | "THICK TONGUE"/"THROAT DRY" INCREASED PULSE 90-100 BPM |
| 54 | 2021-01-26 | chest pain |
Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vac...
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Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vaccine. (per son accompany by patient for vaccine). Pt then became SOB and complained of chest pain. Patient appeared disoriented. EMS already station on the scene was notified by staff. Patient evaluated by EMS.( Patient's son reported patient had mild reaction after 1st vaccine but recovered quickly). Patient was taking to ER by EMS for further evaluation.
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| 54 | 2021-01-26 | heart rate increased |
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we...
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Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
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| 54 | 2021-01-27 | palpitations |
intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-...
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intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of bnt162b2 (Covid vaccine, reported as Pfizer product) lot no: EL0142, via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient experienced intermittent palpitations on 12Jan2021. She has been having palpitations since she received the vaccine, did not start having them until about 8 hours after, stated she has had palpitations on and off since then. The patient had not recovered from the event.
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| 54 | 2021-01-28 | blood glucose increased, blood pressure increased |
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ...
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About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
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| 54 | 2021-02-01 | heart rate increased |
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irrita...
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heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
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| 54 | 2021-02-01 | fainting |
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea...
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kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
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| 54 | 2021-02-02 | palpitations |
Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having in...
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Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having intermittent palpitations and "flushed" feeling in her chest.
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| 54 | 2021-02-02 | palpitations |
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinat...
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On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinate and began to have multiple bowel movement. I began to feel nauseated and very cold with shortness of breath and my heart racing. I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5. I drank water and orange juice thinking it was my blood sugar. I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath. My heart rate was 120. I checked my blood pressure it was 180/120. I was fearful of shock. I continued to pace and warm up with blankets and a space heater. I took a warm bath and my temperature increased to 97.7. I continued to feel my pulse racing. I called Dr. office and got an appointment to see her 8:30 am 1/29/2021. She checked my vitals signs B/P - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs. She did labs and urinalysis. She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction. I will return to see her 2/5/2021.
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| 54 | 2021-02-02 | chest discomfort |
Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot an...
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Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot and cold". Then felt some chest tightness with some difficulty breathing but no wheezing, She felt the tightness sensation on her chest. EpiPen administered once with transient improvement of symptoms but then recurred then administered EpiPen again. Thinks she saw some hives on her chest. Taken by ambulance and administered diphenhydramine 50mg Taken to the ER with no rash, upper/lower respiratory symptoms noted. EKG and cardiac workup negative. Patient discharged after 4 hours after improvement of symptoms with no other treatment given. Serum tryptase sent and 6.4mcg/mL.
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| 54 | 2021-02-02 | hypertension, palpitations |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-03 | heart flutter, chest discomfort, heart rate increased |
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ...
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approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
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| 54 | 2021-02-04 | nosebleed |
Headache; tiredness; nose bleeding; This is a spontaneous report from a contactable consumer (patien...
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Headache; tiredness; nose bleeding; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 20Jan2021 01:30 at a single dose for COVID-19 immunization. Medical history included chronic migraine from an unknown date and unknown if ongoing. Concomitant medication included citalopram and trazodone. The patient was not pregnant. The patient had no other vaccine in four weeks prior vaccination. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced headache, tiredness, she had a nose bleed and added that most of the time, if she had a headache, her nose will bleed. The events occurred on an unspecified date in Jan2021 at 03:00 AM with outcome of recovered in Jan2021. No treatment received for the events.
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| 54 | 2021-02-04 | blood pressure increased |
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ...
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PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
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| 54 | 2021-02-04 | blood pressure increased |
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall...
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Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
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| 54 | 2021-02-04 | blood pressure increased |
Spike in BP143/98, unusual feeling in throat, 50mg of Benadryl administered with water, pt BP came d...
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Spike in BP143/98, unusual feeling in throat, 50mg of Benadryl administered with water, pt BP came down to 124/82 HR 89 O2 97%, The doctor on site is monitoring her
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| 54 | 2021-02-04 | palpitations |
palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-o...
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palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 29Dec2020 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension and obesity. The patient's concomitant medications were not reported. The patient previously took Dilaudid and experienced allergies. With first shot-immediately after (on 29Dec2020) had palpitations. Was nauseous times 24 hours on an unspecified date. The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 54 | 2021-02-05 | heart rate increased |
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy ...
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High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
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| 54 | 2021-02-05 | chest pain |
Pt complained of chest pain within 5 minutes of vaccine at mass vac event. Pt monitored one on one b...
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Pt complained of chest pain within 5 minutes of vaccine at mass vac event. Pt monitored one on one by Dr. pain 8/10 to 5/10 to 2/10 after 10-12 minutes. no SOB, no deficit, no rash, no abd cramping.
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| 54 | 2021-02-07 | palpitations |
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep...
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Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
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| 54 | 2021-02-07 | blood pressure increased |
Increase in blood pressure compared to baseline and headache beginning within two days of first vacc...
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Increase in blood pressure compared to baseline and headache beginning within two days of first vaccine dose. Occipital headache and elevated blood pressure persisted for over two weeks after vaccine and as of reporting date have not resolved.
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| 54 | 2021-02-07 | palpitations |
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE...
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next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
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| 54 | 2021-02-08 | blood pressure increased |
02/05/21 Blood Pressure went up to 166/114; severe headache and threw up; dizzy like spinning Calle...
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02/05/21 Blood Pressure went up to 166/114; severe headache and threw up; dizzy like spinning Called the Doctor's office and was advised to go to the ER immediately
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| 54 | 2021-02-09 | heart rate increased, blood pressure increased |
Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis an...
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Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis and shortness of breath. On VS Heart rate and blood pressure were elevated O2 sat was WNL. Patient w as placed in a supine position and VS were repeated after 15 min and she felt better and VS were now WNL
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| 54 | 2021-02-09 | low platelet count, platelet count decreased | Severe thrombocytopenia (Platelets = 5) and diffuse petechial rash to trunk and extremities |
| 54 | 2021-02-10 | heart rate irregular | Irregular heart rhythm for 1 hour, bounding heart rhythm for 5 hours |
| 54 | 2021-02-10 | fibrin d dimer increased, haemoglobin decreased, low blood platelet count, platelet count decreased |
Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 wee...
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Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 week after the 1st dose, patient said she developed a rash. On presentation on 2/10/21, the rash appeared to be petechial in nature. Prior to coming to the hospital, the patient had blood work done at her ALF and was told she had zero platelets and she was sent to the hospital. Admission labs at the hospital on 2/10 also showed zero platelets and immune thrombocytopenia is suspected.
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| 54 | 2021-02-11 | chest discomfort |
15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and ches...
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15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and chest tightness
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| 54 | 2021-02-11 | body temperature decreased |
Flu-like symptoms reported as- nauseous, chills, aches for 24 hour duration. Patient also reported a...
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Flu-like symptoms reported as- nauseous, chills, aches for 24 hour duration. Patient also reported a low temperature of 94 degrees.
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| 54 | 2021-02-14 | blood pressure increased |
1237 Pt complained she felt "off center" 1300 BP 140/80, )2 98%, HR 58, 1325 She felt better vs no...
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1237 Pt complained she felt "off center" 1300 BP 140/80, )2 98%, HR 58, 1325 She felt better vs no change. She ride home with her sister
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| 54 | 2021-02-14 | loss of consciousness |
1533 Lightheaded post shot pt passed out. BP 182/120, 1540 148/108 pt lying on the floor, respondi...
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1533 Lightheaded post shot pt passed out. BP 182/120, 1540 148/108 pt lying on the floor, responding to nurse. Son was called to meet her at Hospital. 1542 911 called and squad arrived. 1545 Sitting in chair with EMS present. Oriented x3. 1548 Pt ambulated to squad with EMTS. Pt agreed to go to ER. Pt states she passes out after shots. She was advised to inform her PCP.
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| 54 | 2021-02-14 | palpitations |
flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and a...
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flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and again 2 hours later.
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| 54 | 2021-02-15 | chest pain |
c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were...
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c/o sob, CP, throat tightness, tongue tingling minutes after administration of vaccine. Vitals were within normal limits. Alert and oriented. Given IM benadryl and Epi. Transported to ED.
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| 54 | 2021-02-18 | platelet count decreased |
Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report recei...
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Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report received from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Pfizer product), via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history included ongoing possibly has rheumatoid arthritis. No known allergies to medications, food, or other products. Concomitant medication included meloxicam (MOBIC) and multivitamin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Pfizer product), intramuscularly on left arm on 17Dec2020 (54-year-old, Lot number: EH9899) at single dose for COVID-19 immunization. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 11:00, the patient experienced low platelets and had to have a platelet transfusion. The patient visited doctor or other healthcare professional office/clinic and visited emergency room/department or urgent care due to the event. The event was considered as non-serious by the nurse. The outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event low platelets requiring platelet transfusion with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2021-02-19 | palpitations | Felt like heart racing, POx & VS stable. Patient had cortisone shot 2 days prior with rash |
| 54 | 2021-02-21 | chest pain |
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi...
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Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
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| 54 | 2021-02-21 | pulse abnormal |
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108...
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At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
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| 54 | 2021-02-21 | blood pressure increased |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-22 | chest discomfort, arrhythmia, palpitations, chest pain |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | fast heart rate |
Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved ...
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Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved with benadryl
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| 54 | 2021-02-22 | palpitations |
PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. ...
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PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. REDIRECTION AND REFOCUS ATTEMPTED WITH GOOD EFFECT AS NOTED BY HR DECREASE TO 88-103 AND BP 130/88 100% PATIENT DENIED SOB AND CHEST PAIN. MARKED DECREASE IN SYMPTOMS WHEN CALM, HOWEVER, DIFFICULT TO KEEP HER CALM AND SHE WAS CONVINCED THE VACCINE WAS THE CAUSE OF THE SYMPTOMS. DECISION MADE TO TAKE PATIENT TO THE ER FOR EVALUATION. VS ON D/C 98- 138/73 100%; REPORT GIVEN TO RN ER CHARGE
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| 54 | 2021-02-22 | chest discomfort |
Patient became mildly short of breath with some chest tightness and light headedness approximately 2...
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Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine. She notified the nursing counter who notified me. Patient was A&Ox3 upon my arrival and able to speak in full sentences. Heart rate was noted to be 105 bpm. 50mg oral Benadryl was administered and patient was monitored for 25 minutes. Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely. Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site. She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.
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| 54 | 2021-02-22 | chest discomfort |
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied dif...
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Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
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| 54 | 2021-02-23 | blood pressure increased |
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at...
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Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
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| 54 | 2021-02-24 | palpitations |
11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for furthe...
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11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
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| 54 | 2021-02-24 | fibrin d dimer increased, platelet count decreased |
14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple ...
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14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple tests, including CT scans, Lumbar puncture, abnormal lab work with no known cause. High lymphocytes count (abnormal lymphocytes), abnormal red blood cells, high D Dimer, etc.. Most recent labs show Monoclonal paraproteinemia, Im currently waiting to see a hematologist. Have seen internal medicine, infectious disease, rheumatology, . No one can determine the cause of the ongoing symptoms.
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| 54 | 2021-02-25 | fainting, blood pressure decreased |
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu...
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After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
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| 54 | 2021-02-26 | chest pain |
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis...
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Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
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| 54 | 2021-02-26 | chest pain, palpitations | Tingling in head, dizziness, SOB, chest pain, palpitations, evaluated by EMS-cleared |
| 54 | 2021-02-28 | heart rate increased |
Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP ...
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Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP 144/88, p-93, O2sats- 99% on RA. Given water and symptoms resolved within 10 minutes. No chest pain, no shortness of breath, no sensation of tongue or lips swelling. Vitals rechecked 130/78, p-83 and O2sats- 99%. No further symptoms and patient expressed desire to leave.
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| 54 | 2021-02-28 | palpitations | Itchy, and heart racing turned over care to AMR was given oral Benadryl transported to hospital. |
| 54 | 2021-03-01 | cerebrovascular accident, loss of consciousness |
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very...
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I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
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| 54 | 2021-03-02 | chest pain |
pt stated stated she woke up vomiting the next morning after receiving the vax. She also has develo...
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pt stated stated she woke up vomiting the next morning after receiving the vax. She also has developed flu like symptoms. Body aches, headache, chest pain, chills, abdominal cramps and diarrhea. Pt states she has not contacted her PCP at this time.
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| 54 | 2021-03-03 | loss of consciousness |
Patient received her vaccine at 1:12pm. She went to check out. The check out man reported that she d...
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Patient received her vaccine at 1:12pm. She went to check out. The check out man reported that she didn't feel well. I noticed that she started to slump over in her chair. I went to her. I asked if she wanted to lay on the hospital bed. She said she couldn't get up. She wanted cold rags. She was visibly sweating. I motioned another health care worker over so I could go get the rags. When I got back less than 30 seconds later, she was on the floor. My coworker reported she slumped out of the chair and was unconscious for about 10 seconds. Security called 911 , and I called the emergency phone number to the hospital. She came back around and did not want to go to ER. Dr listened to her. Lungs were completely clear. She reports she has a history of dizziness with all vaccines. She has never gone totally unconscious before. She has no history of diabetes or hypertension. She did not eat lunch before coming. BP 123/80 at start of the event. 27 minutes after the event bp was 99/69 with pulse 66. 52 minutes later bp 109/86 with pulse of 71. We did not want her to drive home. We had her call someone to be picked up. She was able to walk out of the building without assistance.
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| 54 | 2021-03-03 | chest discomfort | lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared |
| 54 | 2021-03-04 | palpitations |
patient presented to hospital for heart palpitation in SVT 180-190's. Patient had no light headness ...
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patient presented to hospital for heart palpitation in SVT 180-190's. Patient had no light headness or dizziness. Patient was cardioverted and improved. Discharged 2/18. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
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| 54 | 2021-03-05 | nosebleed |
I had a very unusual nose bleed one hour after taken the shot. I don?t think it was a serious event...
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I had a very unusual nose bleed one hour after taken the shot. I don?t think it was a serious event but bc I don?t remember last time I had a bloody nose thought it was worth reporting
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| 54 | 2021-03-06 | heart rate increased |
-Twitching mostly in my legs and stomach and ribs especially during the first week. It substantiall...
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-Twitching mostly in my legs and stomach and ribs especially during the first week. It substantially subsided during the second week but still occasionally happens in my leg and sometimes in my temple area beside my left eye. -On the first or second day after vaccination, my pulse was beating profusely (fast and furious) between my left thumb and index finger mid-way toward my wrist of my right hand. I am not sure what that was, since I had never seen that happen before and it was not happening on my left hand. I am scheduled to take my second vaccine on 3/15/2021 so I am trying to find out if you would recommend that I take the second vaccine or not take it. I am scheduled to tak
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| 54 | 2021-03-06 | heart rate increased |
Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/8...
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Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/83 (pulse 106), 98% O2 sat.
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| 54 | 2021-03-07 | palpitations | heart palpitations for 3 days, lesser palpitations for 2 more days |
| 54 | 2021-03-08 | nosebleed | Profuse bloody nose with clots for approximately 5 minutes |
| 54 | 2021-03-08 | hypotension |
Pt experienced extreme vertigo within 24 hours of second dose of Pfizer BioNTech vaccine. The vertig...
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Pt experienced extreme vertigo within 24 hours of second dose of Pfizer BioNTech vaccine. The vertigo started 1/29 and had not changed at time of reporting to vaccine call center on 2/1. Patient takes blood pressure medication (unspecified) and has been monitoring her blood pressure. Her blood pressure has been lower than normal and thus she has been drinking a lot of fluids. Patient was directed to go to Urgent Care/ER. Denied any flu-like symptoms.
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| 54 | 2021-03-10 | blood pressure increased |
Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset...
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Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset of dizziness, profuse sweating, shakiness, difficulty speaking, stammering, difficulty sitting or standing without assistance, increased blood pressure, headache in right temple through back of head on right side. Nursing support response included taking me by wheel chair to isolated area, removing face covering, providing drinking water, monitoring pulse and blood oxygen rates and blood pressure. Began to feel better after several minutes, then symptoms returned but not as severe. Cycles of improvement and return of symptoms but diminished in severity occurred over the next 30 minutes. Tired feeling for approximately 4 hours following vaccine and low grade headache. Took 2 Tylenol regular strength approximately 1 hour following vaccine and again 4 hours later. 20 hours following vaccine, still feeling episodes of dizziness, headache, fatigue, difficulty with speech (stammering), shakiness, difficulty focusing/concentrating.
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| 54 | 2021-03-10 | fast heart rate | Tachycardia, tingling in mouth, evaluated by medics, cleared. |
| 54 | 2021-03-11 | chest discomfort |
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning...
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At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
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| 54 | 2021-03-11 | chest discomfort | Brain fog, headache, muscle aches, tightness in chest, nausea |
| 54 | 2021-03-11 | chest discomfort, palpitations |
Patient experienced palpatations and chest tightness. She stated she didn't take her medication. EMS...
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Patient experienced palpatations and chest tightness. She stated she didn't take her medication. EMS was called vitals BP 155/90 patient recovered and was released.
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| 54 | 2021-03-12 | chest pain |
Patient complained of a burning sensation in her chest and she developed neck stiffness, with a diff...
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Patient complained of a burning sensation in her chest and she developed neck stiffness, with a difficulty in turning her head to the left. She was provided diphenhydramine 50mg and water. We monitored her for >30 minutes. Her symptoms did not exacerbate. She had a doctor's appointment at 9:30 and elected to make the visit.
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| 54 | 2021-03-12 | chest discomfort |
patient sat down and started to feel numbness in the face swelling of throat and tightness in chest ...
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patient sat down and started to feel numbness in the face swelling of throat and tightness in chest patient was given an epipen and 911 was called she was taken to emergency room and monitored but currently feeling ok
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| 54 | 2021-03-13 | heart rate increased, heart flutter, blood glucose increased, chest pain |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 54 | 2021-03-14 | blood glucose increased |
2 weeks and 1 day after vaccine, I had an extremely painful headache, 99.5 degree fever and persiste...
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2 weeks and 1 day after vaccine, I had an extremely painful headache, 99.5 degree fever and persistent and intense nausea for five days making it difficult to eat regular meals. I finally pursued treatment at an urgent care and was given a prescription of Zofran which immediately helped with the nausea. I am not sure if this was vaccine related but one of my care providers stated i was the third person that day she had seen taking Zofran for extreme nausea. Urgent care doctor looked for gallbladder issues and had no other explanation.
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| 54 | 2021-03-14 | chest discomfort | SHORTNESS OF BREATH ,PRESSURE IN CHH EST, NAUSEA, FEVER 101-102, SWOLLEN NECK GLANDS |
| 54 | 2021-03-14 | chest discomfort |
Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receivin...
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Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receiving vaccine. Pt has extensive medical hx and hx of severe allergic reactions, carries epi pen with her. Epi (given asap after start of symptoms) and Benadryl given here prior to transfer to ED- Medical Emergency Team immediately called at onset of symptoms and transferred to ER with them.
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| 54 | 2021-03-14 | atrial fibrillation |
increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous repo...
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increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12). The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache. The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2. The event only occurred 4 days after vaccination. And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-03-15 | heart rate increased |
About 10 minutes (moments before they told me sage to leave) I began thinking I was having a hard ti...
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About 10 minutes (moments before they told me sage to leave) I began thinking I was having a hard time breathing but associated it to anxiousness about receiving the vaccine. Ran my errands in town and kept thinking I was having problems breathing. Again, thought I was imagining. For just a minute or so it felt like my throat was tight, but soon vanished so again thought I was imagining. Just didn?t feel ?right? rest of day but assumed I was dreaming it up. That evening when I laid down to go to sleep, I quickly realized I was having shortness of breath. Could barely breath. I checked my oxygen level & it was running 91-94. However, my heart rate (usually sits between 55-65 when resting) was running in high 70?s to mid-80?s. Called ER and asked if I could take Benadryl- they said yes. Took one adult Benadryl and felt a bit better soon after. An hour later took another along with a Pepcid. Eased up enough then I could go to sleep. Didn?t take any more meds, but it was another day & 1/2 before I felt ?normal? (I have CHF so I deal with some sob always).
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| 54 | 2021-03-15 | blood pressure increased |
My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I coul...
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My lips started to tingle (same reaction as cobalt allergy before my lips swell). I asked if I could take benadryl (which I brought with me). The person watching us texted someone and they came in and looked at me, asked me what was happening, took my blood pressure and said to take 2 benadryl. I told the nurse I only take one benedryl when this happens. She said take 2 benadryl. I did take 2 benadryl 12 minutes after my vaccine. My blood pressure went up. They called an ambulance and I went to the Hospital. My blood pressure was 176/105 at 11:50 am. While I was in the ER, I took a selfie and noticed that I had a rash. No one mentioned that earlier so I am guessing that is why they had me take 2 benadryl. At the ER I was put on an IV - NS .09% 1000ML at 12:27 pm. Then at 13:04 I was given Pepcid 40 MG/NS 250 ML IV at 500 ml/hr intravenous. At 1:12 pm my blood pressure was 138/96 and at 2:31 pm it was 135/70. My rash went away then. Up until last week I have been taking benadryl and/or pepcid everyday since the vaccine. I would still get a rash. I have not had the rash for about 5 days.
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| 54 | 2021-03-15 | blood pressure increased, chest discomfort |
Post vaccine, patient reported feeling "strange", HR 170, BP elevated. Reported feeling "anxious". P...
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Post vaccine, patient reported feeling "strange", HR 170, BP elevated. Reported feeling "anxious". Patient stated she had not taken her blood pressure medicine today. Oxygen applied at 2 lpm for report of chest "pressure". Patient refused EMS transport to hospital for evaluation. Benadryl 50 mg given PO. Prior to discharge, HR in low 100's, BP remained elevated.
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| 54 | 2021-03-15 | blood glucose increased |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by MD at 3/16/2021 9:55 AM Ex...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by MD at 3/16/2021 9:55 AM Expand AllCollapse All COVID VACCINE CLINIC 3/15/2021 Patient: Date: 3/15/2021 MRN: 10187641 Subjective Patient is a 54 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, dizziness and nausea. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and vomiting. Diabetic on metformin and levemir. Ate about 2 hours ago. Did not check her sugars today. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches + nausea: Previous Reactions: none Objective Vitals Vitals: 03/15/21 1003 03/15/21 1022 BP: (!) 149/86 123/67 Pulse: 85 SpO2: 99% Blood Sugar 171 collected at 1007 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water, snacks and pepcid for nausea Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Nausea/lightheaded. Symptoms resolved. VS stable. Exam reassuring. Pt reports feels comfortable going home. She is ambulatory and is appreciative of today's care. Pt is predominantly Spanish-speaking. Translator used: Myself. APRN Electronically Signed 3/15/2021 10:18 AM
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| 54 | 2021-03-17 | palpitations |
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li...
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Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
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| 54 | 2021-03-17 | heart flutter, palpitations |
approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensati...
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approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensation- restless ness
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| 54 | 2021-03-17 | blood pressure increased, heart rate increased |
c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty ...
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c/o acute onset occipital headache, R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report. No resp difficulty. Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85. 12:30pm Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction. All transport to closest ER.
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| 54 | 2021-03-20 | chest pain |
Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of ...
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Itching, , severe headache, swelling or lump under right armpit with severe pain, pain in area of injection , chest pain , runny nose, chills, fever, nausea, fatigue, muscle and body aches especially on right side.
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| 54 | 2021-03-21 | heart flutter, palpitations | Heart palpitations, fluttering |
| 54 | 2021-03-21 | hypotension |
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 MRN: 3150851 Subjective Patient is a 54 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience hives. She denied difficulty breathing, difficulty swallowing, wheezing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient complains of hives (1 hive on chest) Patient denies chills, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies prior reaction to vaccines Objective Vitals Vitals: 03/22/21 0828 03/22/21 0846 BP: (!) 153/87 (!) 141/69 Pulse: 52 SpO2: 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Comments: +erythematous hive on anterior chest. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Encouraged patient to take benadryl prior to getting her second vaccination. PA-C Electronically Signed 3/22/2021 8:55 AM
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| 54 | 2021-03-22 | heart rate increased |
8 minutes after receiving vaccine, I realized I was having trouble swallowing. My heart rate rose ...
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8 minutes after receiving vaccine, I realized I was having trouble swallowing. My heart rate rose quickly getting as high as 156 and staying in the 100-120 rate for almost 3 hours. It would not stay down. I also had trouble taking adeep breaths.
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| 54 | 2021-03-22 | hypertension |
I had a headache and was sick at my stomach within 20 minutes of the vaccine. The ambulance worker c...
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I had a headache and was sick at my stomach within 20 minutes of the vaccine. The ambulance worker checked my blood pressure and it was high for me 158/89. That night it felt like my joints were on fire and my muscle felt like I had been beaten with a bat for a week. I am due for a second vaccine on 3/30/2021. I have not reported this to my primary physician or Rheumatologist.
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| 54 | 2021-03-23 | chest discomfort, chest pain | Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog |
| 54 | 2021-03-24 | palpitations |
Code green called: Patient stated that her face was starting to feel hot and red. Pt. also said he...
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Code green called: Patient stated that her face was starting to feel hot and red. Pt. also said her heart is pounding. Pt. c/o throat swelling but able to talk in full sentences without any distress. Paramedic and Dr. responded. Assessed pt. and took VS. VS as follows: BP 178/86, HR 68, RR 18, O2SAT 100% on RA. Pt. observed for 30 mins. total. Pt. refused to go to ED at this time. Advised by paramedic and Dr. to take benadryl 2 tabs when she gets home and to continue to monitor for worsening symptoms and to go to the nearest ED if needed.
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| 54 | 2021-03-24 | blood clot, nosebleed |
Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneou...
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Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, intramuscular on 08Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had a major nosebleed with blood clots on an unknown day in Mar2021. The patient reported that he never got nosebleeds before. There was no treatment taken for the event, it stopped on itself. The outcome of the events was unknown.
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| 54 | 2021-03-24 | palpitations | Over 101 fevers, headaches, nausea, vomiting, body aches, heart racing, exhaustion, diarrhea. |
| 54 | 2021-03-24 | chest pain, lightheadedness |
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;...
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delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
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| 54 | 2021-03-25 | vaginal haemorrhage |
Vaginal bleeding (like period) but after menopause. I haven?t had a period since 2018 and yesterday ...
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Vaginal bleeding (like period) but after menopause. I haven?t had a period since 2018 and yesterday I basically got my period again. Lots of backache and ovary pain.
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| 54 | 2021-03-26 | hypertension |
DIZZINESS, NAUSEA, DIFFICULTY BREATHING, HIGH BLOOD PRESSURE (165/96), 11:20AM - 11:40AM, PT WAS CON...
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DIZZINESS, NAUSEA, DIFFICULTY BREATHING, HIGH BLOOD PRESSURE (165/96), 11:20AM - 11:40AM, PT WAS CONCIOUS AND DISORIENTED, WE CALLED AMBULANCE WHEN SHE STATED DIFFICULTY BREATHING.
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| 54 | 2021-03-26 | heart rate increased, hypertension |
Patient had sensation of throat closing, rapid heart rate, trouble swallowing, headache and high bl...
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Patient had sensation of throat closing, rapid heart rate, trouble swallowing, headache and high blood pressure all immediately - resolved in about 20 minutes
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| 54 | 2021-03-26 | heart rate increased |
Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. ...
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Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. I had rapid heartbeat for 2 1/2 weeks after the first dose and almost did not return for the 2nd dose because of this.
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| 54 | 2021-03-27 | excessive bleeding |
Bleeding of gums; unbake to stop bleeding from puncture site; This is a spontaneous report from a co...
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Bleeding of gums; unbake to stop bleeding from puncture site; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 54-years-old) at 18:00 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amiloride taken for an unspecified indication, start and stop date were not reported. On 01Mar2021 at 06:00, the patient experienced bleeding of gums beginning less than 48 hours after dose, then 1 week after dose, donated blood, "unbake" to stop bleeding from puncture site on Mar2021, tourniquet applied and blood soaked through, was oozing for 5 hours after. There was no treatment received for the events. The outcome of the events was unknown.
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| 54 | 2021-03-27 | palpitations, cardiac arrhythmia |
I developed palpitations Saturday night after receiving my 2nd vaccine dose at 6pm, January 9th. Th...
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I developed palpitations Saturday night after receiving my 2nd vaccine dose at 6pm, January 9th. The palpitations continued through out the day/night on Sunday January 10th. When I went to work on Monday morning, January 11th, I put myself on an EKG monitor and it showed unifocal PVCs. (I made a short video recording.) The PVCs seemed to be gone by Tuesday afternoon. Also, on March 17th, I experienced sudden stabbing/sharp pain above/around my left eye which persisted for about 10 minutes. It was excruciating and I have not had anything like that before in my life. Although the stabbing feeling has not returned, I have a dull pain above that eye now that persists.
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| 54 | 2021-03-28 | heart rate increased |
Had a rapid heart rate. It was at 100 bpm or higher while resting. Stayed at that rate for about 2...
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Had a rapid heart rate. It was at 100 bpm or higher while resting. Stayed at that rate for about 24 hours and then dropped to about 90. My normal heart rate is below 80 (sometimes lower than 70). Still not completely back to normal, but coming down.
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| 54 | 2021-03-28 | ischemic chest pain, blood pressure increased |
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed...
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heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
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| 54 | 2021-03-29 | troponin increased |
Completed my vsafe check in each day. Very mild symptoms. On day six I had what appeared to be a sev...
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Completed my vsafe check in each day. Very mild symptoms. On day six I had what appeared to be a severe asthma attack (no history of asthma) while working outside. Continued working and symptoms increased, oxygen levels dropped, ended up in ER with elevated triponin. Echo and angiogram both normal healthy heart.
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| 54 | 2021-04-02 | pulmonary embolism, blood clot |
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ...
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After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
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| 54 | 2021-04-04 | chest pain, heart rate increased |
The next day after the vaccine I had chest pains and severe headaches. After a week of this I went ...
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The next day after the vaccine I had chest pains and severe headaches. After a week of this I went to Urgent Care and they send me to the ER with Chest Pain and High Heart Rate. They were not able to get my heart rate down in the ER so they decided to admit me to hospital and run some tests on me. Several hundreds of dollars later they have no diagnosis. I am now on blood pressure medicine for a month to see if this helps my blood pressure.
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| 54 | 2021-04-07 | lightheadedness, hypertension |
Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to...
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Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events. Information for lot/batch number has been requested.
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| 54 | 2021-04-12 | chest discomfort |
neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore ac...
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neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore achy bones, muscle; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via an unspecified route of administration at the left arm on 27Mar2021 12:45 pm at single dose for COVID-19 immunization. The patient's medical history included juvenile rheumatoid arthritis, asthma, diabetic Type 2, neurological seizure disorder from traumatic brain injury. The patient had known allergies to penicillin, tetracycline, sulfonamide. Concomitant medications included methotrexate (withheld for 2 weeks 25mg injection). On 28Mar2021 1:15 AM, the patient experienced neurological grand mal seizures, sore achy bones, muscle, tight chest, and difficulty breathing. The patient was treated with nebulizer for difficulty breathing. It was reported that patient had no covid prior vaccination nor tested post vaccination. Outcome of events was reported as not recovered.
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| 54 | 2021-04-14 | haemoglobin decreased, platelet count decreased |
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting,...
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Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting, and abdominal cramping, Presents to oncology clinic with fever (temp 38.5 Celsius), rigors, and chills. Patient admitted to oncology service for fever and rigors while on immunosuppression.
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| 54 | 2021-04-14 | heart rate increased, fast heart rate |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
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| 54 | 2021-04-17 | chest pain, heart rate increased |
my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my st...
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my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my stomach to relieve the pressure and pain in my chest.; I was having troubling breathing; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose (lot number: 6207) of the same vaccine on 09Mar2021 at 06:30 am in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient reported that she had the second dose at 6:30 p.m. By 10:30 a.m. the next day she started coughing all of a sudden. Needed to take an inhaler to some what calm it down. Her heart started raising. That evening she had to lay on her stomach to relieve the pressure and pain in her chest. The following day went to the doctor because her heart was raising so much that she was having troubling breathing and her chest hurt. They did an EKG it was concerning of how fast her heart was beating. That same day the patient was sent to a cardiologist. Her heart was still raising and they did a EKG and the beats were about average. So then she had an Cardio gram and that was normal. The next day the doctor called and gave her the ECO reports and the cardiologist believed it was from the vaccine. The onset date of all adverse events was reported as on 31Mar2021 at 10:30AM. All events were reported as non-serious by reporter. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of all the events was unknown.
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| 54 | 2021-04-18 | haemoglobin decreased, platelet count decreased |
Daily fever as high as 103 since I received the second vaccine. The fever is generally occurring n...
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Daily fever as high as 103 since I received the second vaccine. The fever is generally occurring nightly but has been ongoing since March 19, 2021. My platelets dropped down to 93 from a steady value while undergoing chemo in the mid 200 to 300's. Hemoglobin was on steady decline but suddenly tanked such that I need a blood transfusion. My rectal tumor is now ulcerated and began leaking mucus and blood after the second shot. I believe the vaccine has attacked my rectal tumor adversely which is now causing my fever to be ongoing along with these other symptoms. Prior to the second vaccine I have no fevers from my rectal tumor and no leakage.
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| 54 | 2021-04-18 | cerebrovascular accident |
Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of u...
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Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
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| 54 | 2021-04-20 | blood clot |
Extreme inflammatory response. In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in...
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Extreme inflammatory response. In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in Obtuse Marginal; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Lot Number: EN6207), age at vaccination of 54-years-old, as single dose for covid-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing, connective tissue disorder from an unknown date and unknown if ongoing. Patient was not pregnant. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported; isosorbide mononitrate (IMDUR) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity. The patient experienced extreme inflammatory reaction on 24Mar2021 at 04:00 AM and clot blood on 24Mar2021; events were serious as resulted in Emergency room/department or urgent care, hospitalization (for 5 days), life threatening illness (immediate risk of death from the event). The patient had extreme inflammatory response; in ER/hospitalized 5 days post vaccine. Angiogram was performed and clot in obtuse marginal was found; unable to remove clot, surgeon was able to break it apart and balloon the vessel open. It was unknown if patient had COVID prior vaccination. Patient had no other vaccine in four weeks. Sars-cov-2 test was negative on 15Apr2021. The patient was considered to be recovering from the events.
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| 54 | 2021-04-24 | hypertension, heart rate increased |
fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a ...
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fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM. The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event). Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
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| 54 | 2021-04-24 | chest pain, loss of consciousness |
pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or l...
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pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or lymph node related; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep6955), via an unspecified route of administration, administered in arm left on 23Mar2021 15:45 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included Hashimoto's from an unknown date. The patient had known allergies to shellfish. The patient had no covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); cyanocobalamin (B 12); magnesium; and cetirizine hydrochloride (ZYRTEC); all were taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 16:30 45-minutes after getting the shot the patient had a sharp pain on the left side of her chest that continually got worse. It seemed muscle or lymph node related - and eventually got to the point where she couldn't easily move without feeling like she was going to pass out from the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included prescription pain reliever and muscle relaxant. The outcome of the events was recovered. The patient did not covid tested post vaccination.
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| 54 | 2021-04-24 | loss of consciousness |
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so...
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passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-24 | blood pressure increased, chest pain |
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ...
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severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
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| 54 | 2021-04-27 | chest discomfort |
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'...
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Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
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| 54 | 2021-04-29 | blood pressure decreased, loss of consciousness, fainting |
Became slightly dizzy within ten minutes of vaccination. Increasing dizziness became severe. Passed ...
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Became slightly dizzy within ten minutes of vaccination. Increasing dizziness became severe. Passed out completely while sitting down. Woke up with an IV in my arm. Medic said my blood pressure had dropped dangerously low. Was loaded onto stretcher and transported by ambulance to the hospital ER. Blood pressure and pulse monitored. Received EKG, blood, and urine tests. No reported abnormalities. Discharged after three hours. Formal diagnosis was Syncope, a fainting episode.
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| 54 | 2021-04-30 | heart rate increased, fainting, hypertension |
high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; s...
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high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 54 | 2021-05-02 | palpitations, hypertension |
5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. Th...
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5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. The back of my head felt heavy. I notified the nurse who measured my blood pressure which was at hypertension levels of 175/98 for 50 minutes and they called 911. They recommended that I go to the ER because my blood pressure kept rising at 45 minutes. After 1.5 hours, I measured my blood pressure at home and it was at 124/75. It took 5 hours for my blood pressure to be at 112/57. I have always been in the normal blood pressure range, so I believe the symptoms were due to the vaccine.
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| 54 | 2021-05-03 | heart rate increased |
feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after...
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feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after the first injection; she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously; arm hurt but not very much, arm was just tender; ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (Patient). A (Age: 54; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EP7534, expiry date not reported) via unspecified route in left arm on 26Mar2021 at 14:40 PM as single dose for COVID-19 immunization. Medical history included anxiety disorder (ongoing), bipolar disorder (ongoing) and bipolar with panic disorder. Concomitant medication included unspecified medication (When probing concomitant medications, she reports she'd been taking psychiatric medications since she was in her 20's. She'd been on all her current medication for at least 3 months or more). No other vaccine in four weeks. The patient experienced feeling unwell, not healthy, arm hurt but not very much, arm was just tender, headache, sore throat, chest cough on an unknown date, ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit, she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously on 26Mar2021 and she tested positive for covid after the first injection on 01Apr2021. Caller stated she caller to report an experience to the pfizer covid 19 vaccine. Caller stated she had the first dose of the Pfizer covid 19 vaccine on 26Mar2021. Caller stated she tested positive for covid after the first injection and ran a fever of 101 to 104 for seven days. Caller stated she has had increased resting pulse rate from 90 to between 122-125. Caller stated her pulse rate is usually in the 60's mostly 64. Caller stated she was feeling unwell, not healthy. Caller stated she was bipolar with panic disorder and is very scared at this point to get the second dose. Caller wanted to confirm that her increased resting pulse could be a severe allergic reaction. Caller wanted guidance about if or when to receive the second dose. Caller already reported to safety. Caller confirmed her concern was about the increased resting pulse. Caller asked since she had covid, was she protected for 90 days. She was calling about the Covid 19 vaccine. She had her first dose on 26Mar2021, and she immediately had a reaction to it. She had a very high, elevated, resting pulse, it was 94bpm. Since she had received the Covid 19 vaccine her pulse has been over 100 beats per minute continuously. The other thing that was peculiar was that she tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. She had concerned that her pulse has not returned to normal. She has a question about when and if she should get the second Covid 19 vaccine. She was currently scheduled to receive her Covid 19 vaccine on 26Apr2021. She does suffer from an anxiety disorder and bipolar disorder so her pulse rate has been especially frightening for her. She is relieved because her husband has been reading and he's seen some stuff online that people have mental symptoms after the Covid 19 vaccine. She felt better knowing that her medication was still working. Meaning her medication for her anxiety disorder and bipolar disorder is still working. She has no further information on the people online. She reports her arm hurt but not very much. That started the same day that she received the vaccine. Her arm was just tender, she was aware of her arm. Her arm was only tender about 4-5 days. Her arm isn't bothering her now. She did suffer with a high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit starting on the day she received the Covid 19 vaccine. She's had no fever at all for the last 2 weeks. The only symptom that remains is her increased pulse. She got the Covid 19 virus test on 01Apr2021. She's not sure if was the rapid or the longer Covid 19 test. She received her results in about 24 hours. She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever, she went to the emergency room. She was on her second bottle of Tylenol. She reports the first bottle was the brand name of Tylenol, but she has discarded the bottle. It was the 4-hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol was the (Company name) Tylenol knock off brand of Acetaminophen. Each tablet was 650mg take 2 tablets every 8 hours as needed. Lot# unknown, NDC 0363-0336-01, Expiry Sep2022. She had to get her glasses to read the print on the (Company name) Tylenol knock off brand. She went to the emergency room because the Tylenol was no longer keeping her fever down and she got frightened. She did not have the Covid 19 test at the emergency room, she had the Covid 19 test. She was sent home from the emergency department. She was not admitted to the hospital. She reports the Covid 19 virus definitely moved through her body starting with a headache, sore throat, and a chest cough. She reports her symptoms lasted a bit longer than her fever. She reports the chest cough lasted the longest. She reports that some people think the Covid 19 vaccine would give you the Covid 19 virus. She believes she had the Covid 19 virus before she received the Covid 19 vaccine. She reports she might have remained asymptomatic until she received the Covid 19 vaccine. The event high fever, elevated heart rate resulted in emergency Room. The outcome of event Pulse rate increased was not recovered, Pain in arm was recovered, whereas unknown for all other events. Description of complaint: PC 1: Tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. Received Covid 19 vaccine on 26Mar2021, tested positive on 01Apr2021. Lot# EP7534 in the left arm NDC/Expiry not known PC 2: She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever she went to the emergency room. She reports the first bottle was the brand name of Tylenol but she has discarded the bottle. It was the 4 hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol is the (Company name) Tylenol knock off brand. Acetaminophen. Each tablet is 650mg take 2 tablets every 8 hours as needed. Lot# unknown NDC 0363-0336-01, Expiry Sep2022 PC 3: She has to get her glasses to read the NDC/Expiry from the (Company name) Tylenol knock off brand. NDC 0363-0336-01 Expiry Sep2022, Lot # unknown No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-05-04 | deep vein blood clot, blood clot |
I went back to the hospital and couple days later they told me that actually I have Deep vein thromb...
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I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported; (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported. After second dose on 29th (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that "the arm was much better now and not really sore". The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days. The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.
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| 54 | 2021-05-06 | blood clot |
After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose ...
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After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose given 04/23/21 and by 04/28/2021 I started bleeding again And by the second day I was soaking through pads and huge clots were coming out. This has never happened to me before. After 7 days of bleeding heavily I woke up on May 5th at 4:00 a.m. with intense abdominal cramping The only way I can describe was labor. I felt back labor, pelvic pressure, frequent urination and intense pain. I reached out to my gynecologist And he immediately told me to remove my estrogen patch and later that morning he started me on progesterone treatment for 10 days to stop the bleeding. After 7 hours of pain on May 5th, I went to the emergency department and an ultrasound revealed a blood clot. From ultrasound results "there is a complex area in the area of the cervix measuring 5.7 x 3.6 x 2.6 cm." After several hours I was released from the emergency room taking toradol for pain. That evening I passed a huge blood clot! I'm very grateful it was where it was and I could expel it. But there's no doubt the second vaccine caused this issue that has never happened to me before. I still get my periods though irregular and very light. So this event was highly unusual and very painful
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| 54 | 2021-05-07 | oxygen saturation decreased, fainting |
Fainted; low pulse oxygen level; Fainted; low pulse oxygen level; This is a spontaneous report from ...
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Fainted; low pulse oxygen level; Fainted; low pulse oxygen level; This is a spontaneous report from a contactable consumer. A 54-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 at a health clinic facility, via an unspecified route of administration, administered in left arm on 25Apr2021 11:45 AM (age at vaccination: 54 years; Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. Medical history was reported as none and patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination patient had not been tested for COVID-19. The patient experienced fainted; low pulse oxygen level on 25Apr2021 11:45 am. No treatment was given. Patient recovered on an unspecified date from fainted; low pulse oxygen level.
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| 54 | 2021-05-10 | loss of consciousness, chest pain |
was going to blackout; Body aches; headache; chills; nausea; Chest pain; This is a spontaneous repor...
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was going to blackout; Body aches; headache; chills; nausea; Chest pain; This is a spontaneous report from a contactable consumer reported for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 20:30 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Heart murmur. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as 1st dose, single for COVID-19 immunization. On 25Apr2021 16:00, the patient experienced body aches, headache, chills, nausea and chest pain, chest pain was severe with chills, felt like she was going to blackout, her husband propped her up in bed, gave Advil and a cool rag for her head, temp was 98.3 Fahrenheit. Outcome of the events were unknown. Follow up attempts needed. Further information is expected.
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| 55 | 2021-01-01 | palpitations |
Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own af...
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Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.
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| 55 | 2021-01-01 | chest pain |
Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved ...
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Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.
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| 55 | 2021-01-03 | fainting, fast heart rate |
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling s...
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5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
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| 55 | 2021-01-03 | chest pain |
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi...
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Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
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| 55 | 2021-01-04 | hypotension | Agitation, Sedation, Anaphylaxis, Rash & HYPOtension |
| 55 | 2021-01-04 | body temperature decreased |
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ...
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PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
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| 55 | 2021-01-04 | heart rate increased |
Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed fee...
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Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-05 | chest discomfort |
5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lig...
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5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
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| 55 | 2021-01-05 | lightheadedness |
Patient was very nervous prior to vaccination, and immediately after the injection, she developed va...
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Patient was very nervous prior to vaccination, and immediately after the injection, she developed vasovagal reaction. It took her at least 30 minutes to recover, but was stable and went home with spouse.
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| 55 | 2021-01-05 | lightheadedness |
Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasova...
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Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasovagal reaction. It took her at least 30 minutes to recover, but was able to go home with spouse.
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| 55 | 2021-01-05 | chest pain, fast heart rate | Rash, chest pain, tachycardia, numb tongue, hard to swallow |
| 55 | 2021-01-05 | fainting | Syncopal episode went to ER and required stitches |
| 55 | 2021-01-05 | chest discomfort | Temperature, cough, chest pressure, fatigue, redness and bump at immunization site |
| 55 | 2021-01-05 | hypertension |
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa...
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Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
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| 55 | 2021-01-06 | fast heart rate |
Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observatio...
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Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm
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| 55 | 2021-01-06 | fainting, palpitations |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-06 | chest pain, palpitations |
Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same...
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Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same reaction after the first dose. She felt her heart racing and throat closing with chest pain. She received diphenhydramine 25 mg IV, famotidine 20 mg IV, and methylprednisolone 80 mg IV.
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| 55 | 2021-01-06 | chest discomfort, palpitations |
Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a ...
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Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a drink. When the drink did not help she was given 12.5mg of diphenhydramine at 4:57pm. It was recommended and offered for her to take 25mg of diphenhydramine but patient stated it made her too drowsy. After a few minutes, the patient stated it felt like her throat was tightening so she was given the other 12.5mg of diphenhydramine given at 5:03pm. She stated her heart was racing and her head was pounding. Her blood pressure was 164/72 and pulse 117. She stated her chest was feeling tight and at 5:11 an EpiPen was administered and call to 911.
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| 55 | 2021-01-06 | blood pressure increased, palpitations |
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ...
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Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
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| 55 | 2021-01-07 | heart rate increased |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | excessive bleeding |
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ...
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Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
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| 55 | 2021-01-07 | fast heart rate |
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ...
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within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
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| 55 | 2021-01-08 | blood pressure increased |
SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest an...
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SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.
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| 55 | 2021-01-10 | blood pressure fluctuation |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-10 | chest discomfort |
Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not sub...
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Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | chest discomfort |
Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not su...
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Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not subside after 30 minutes of observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | palpitations |
Shortly after administration of the vaccine on 1/7/21, the patient experienced heart palpitations. ...
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Shortly after administration of the vaccine on 1/7/21, the patient experienced heart palpitations. Continued all day and into the next day. The patient contacted PCP on 1/8/21. PCP indicated since a recent stress test was done (12/1/20), no need for an EKG. Per patient, PCP thinks the patient has acid reflux (actively taking omeprazole 20mg/day). Palpitations have resolved.
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| 55 | 2021-01-11 | heart rate increased |
PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOM...
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PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOMS RESOLVED
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| 55 | 2021-01-12 | chest discomfort |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-12 | fainting | Systemic: Fainting-Medium |
| 55 | 2021-01-12 | chest discomfort | chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw |
| 55 | 2021-01-12 | fast heart rate |
headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontan...
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headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for work. The patient's medical history and concomitant medications were reported as none. The patient reported events of fever, headaches, body aches, joint pain, tachycardia, on 07Jan2021. Patient developed fever in the night, 100.5 at 1-3 am. Then, developed body ache and especially joint ache. She had a bad headache from 2-3 am. She also experienced a fast heart beat that started around 2-3 am. She received the vaccine at work. She started taking the paracetamol (TYLENOL) which did pushed down her fever. She thought it helped her headache as well and it helped her heart rate. Her headache was controlled with paracetamol. So she could not tell if it was improving, persisting, or worsening. Her heart rate at around 2-3 am was 115bpm, after paracetamol it got down to 105 bpm. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events fever and tachycardia was recovering, outcome of event headaches was unknown, outcome of the other evets was not recovered. The report was reported as non-serious.
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| 55 | 2021-01-13 | chest discomfort |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | chest pain |
Patient developed chest pain 5 minutes after vaccine administration. Patient was transferred to the ...
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Patient developed chest pain 5 minutes after vaccine administration. Patient was transferred to the EC and was given ASA, EKG (WNL), chest x-ray (negative) IV fluids and then DC home.
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| 55 | 2021-01-13 | palpitations, heart rate increased |
about an hour and a half after the injection I noticed my heart was beating very fast and hard. it ...
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about an hour and a half after the injection I noticed my heart was beating very fast and hard. it was waking me up at night due to the pounding. It has remained this way since i have had the injection on Dec 30, 2020.
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| 55 | 2021-01-14 | blood pressure decreased |
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of t...
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Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine. The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
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| 55 | 2021-01-15 | pallor |
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when...
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Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4. Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
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| 55 | 2021-01-15 | chest pain, palpitations |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-16 | palpitations |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-17 | chest pain, palpitations |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-17 | chest discomfort, heart flutter |
Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A...
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Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EK5730; expiration date: not known), via an unspecified route of administration in the left arm at hospital on 31Dec2020 10:00 at at single dose for COVID-19 immunization. Medical history included known allergies with sulfa. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took clarithromycin (BIAXIN), metronidazole benzoate (FLAGYL), and sulfamethoxazole, trimethoprim (BACTRIM), and all but experienced allergies (reported as "known allergies: Biaxin, Flagyl, sulfa, Bactrim"). No COVID prior to vaccination and no COVID tested post vaccination. The patient experienced heart fluttering and chest pressure on 04Jan2021. There was no treatment received for the reported events. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between the reported heart fluttering and the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-17 | vaginal haemorrhage |
Profuse watery vaginal bleeding 12 hrs after injection. Bleeding lasted approximately six hours. Aft...
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Profuse watery vaginal bleeding 12 hrs after injection. Bleeding lasted approximately six hours. After first injection and vaginal bleeding, gynecology exam completed for abnormalities; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 22Dec2020 at 16:00 at a single dose; and the second dose via intramuscular in the left arm on 08Jan2021 at 08:00 at a single dose as COVID-19 vaccine. Medical history included a known latex allergy and previous spontaneous cerebral artery dissection x 3 ( nonspecific connective tissue disease). The patient was not pregnant at the time of vaccination and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications (reported as other medications within two weeks of vaccination) included estrogens conjugated (PREMARIN), micronized progesterone, colecalciferol (Vitamin D), folic acid (FOLATE), and diphenhydramine hydrochloride (BENADRYL). On 23Dec2020, the patient experienced profuse watery vaginal bleeding 12 hours after the injection. The bleeding lasted approximately six hours. After the first injection and vaginal bleeding, a gynecology exam was completed for abnormalities. Previously diagnosed uterine fibroids present and some free fluid in the pelvis by ultrasound. Bleeding resolved by the end of post-vaccine day 1. After the second vaccine, heavy vaginal bleeding started 10 hours after a injection. It was reported that the adverse event result in a doctor or other healthcare professional office/clinic visit. Treatment for the event involved removal of the IUD. Outcome of the event was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information about the lot/batch number has been requested.; Sender's Comments: There is reasonable possibility that the event vaginal hemorrhage is related to suspect drug BNT162B2 based on a compatible temporal relation between vaccination and the onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-18 | palpitations |
Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15...
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Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15 mins. PT vitals returned to normal within 10 mins. Pt discharged home with friend.
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| 55 | 2021-01-18 | chest discomfort | General malaise and chest tightness |
| 55 | 2021-01-18 | chest discomfort |
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheade...
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I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
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| 55 | 2021-01-18 | palpitations |
Reported heart palpitations, shortness of breath and headache. Transferred to the ED. Feeling better...
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Reported heart palpitations, shortness of breath and headache. Transferred to the ED. Feeling better 1/19. Will follow up with PCP.
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| 55 | 2021-01-18 | palpitations | Reported sharp pain to the left arm, heart palpitations. Symptoms resolved. Will follow up with PCP. |
| 55 | 2021-01-18 | fainting | Syncopal episode |
| 55 | 2021-01-19 | blood pressure increased, palpitations |
Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past m...
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Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past medical history no surgical history.
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| 55 | 2021-01-19 | palpitations, blood pressure increased, heart rate increased |
Patient experienced heart palpitations, increased heart rate (100) and increased Blood pressure (210...
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Patient experienced heart palpitations, increased heart rate (100) and increased Blood pressure (210/120) - patient sent to ER via ambulance
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| 55 | 2021-01-19 | chest discomfort |
Per patient she began experiencing shortness of breath and tightness in her chest a few minutes aft...
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Per patient she began experiencing shortness of breath and tightness in her chest a few minutes after vaccine administration. Pt reports using her inhaler and nebulizer treatments with relief in symptoms. Symptoms have persisted for 24 hours.
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| 55 | 2021-01-19 | heart rate irregular, heart rate decreased |
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and i...
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on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
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| 55 | 2021-01-20 | heart rate increased |
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va...
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After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
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| 55 | 2021-01-20 | blood pressure increased | Second day my arm felt really heavy 5th day I started getting anxious and my blood pressure elevated |
| 55 | 2021-01-20 | fainting, heart rate increased |
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chi...
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several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-21 | body temperature decreased |
1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/202...
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1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/2021 cold, low temp 93F, then registering "Low" on hand help Temp unit. Temp unit did register normal temp for other people so not a issue with unit. naseaous, very tired. resolved by 1/22/2021
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| 55 | 2021-01-21 | oxygen saturation decreased |
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot...
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Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
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| 55 | 2021-01-21 | fast heart rate | Muscle pain, tachycardia, headache, insomnia, nasal congestion |
| 55 | 2021-01-21 | chest discomfort | SORE THROAT, CONGESTION, FUNNY FEELING IN CHEST (UNSURE HOW TO DESCRIBE), TEMP 99-100, MILD ACHINESS |
| 55 | 2021-01-22 | blood pressure increased |
I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of ad...
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I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of adrenaline starting in toe,s that then traveled to my chest. I felt this wave come over my body and I knew something was wrong. I have HIGH BP, so i know what symptoms indicate another high BP event. . I measured my BP and it rocketed to 180/150. This event lasted less than five minutes. I ingested One Clonidine tablet and my pressure decreased. Outside of that ONE incident I had very little adverse events.
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| 55 | 2021-01-24 | cardiac arrhythmia, palpitations, chest pain, chest discomfort |
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d...
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I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
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| 55 | 2021-01-24 | loss of consciousness, fainting |
Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted an...
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Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted and hit my head, was unconscious a couple of minutes.
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| 55 | 2021-01-26 | heart rate increased |
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp...
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Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
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| 55 | 2021-01-28 | fast heart rate, blood pressure increased | Dizziness for 4 days Swollen face Increased Heart Rate and Blood Pressure |
| 55 | 2021-01-28 | platelet count decreased |
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Sat...
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Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
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| 55 | 2021-01-29 | heart rate increased, body temperature decreased |
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada...
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Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
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| 55 | 2021-01-30 | chest discomfort |
Pt starting getting a rash on the arm they received the vaccine. Rash spread to other arm, chest and...
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Pt starting getting a rash on the arm they received the vaccine. Rash spread to other arm, chest and back. She is complaining of some small tight chest. Pt was given PO benadryl
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| 55 | 2021-01-31 | palpitations |
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (fel...
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Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-31 | palpitations |
The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient rep...
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The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called 911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104. For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
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| 55 | 2021-02-01 | blood pressure increased |
2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as ...
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2.25 hours after receiving the vaccine, patient began to feel numbness around her mouth, as well as a constricted feeling in her throat with some difficulty swallowing. Patient was given 25 mg of Benedryl, and later, 40 my of Pepcid, and throat constriction went away but feeling of numbness remained for a while. Her BP generally runs high, but was elevated at 160/100 (1:20 pm), then lowered to 138/89 (1:52 pm). Patient returned to work at 2:06 pm after symptoms had resolved.
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| 55 | 2021-02-01 | palpitations |
20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real fogg...
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20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real foggy for the first 30 minutes after the shot. 15 minutes after benadryl I felt better. One week later I started itching especially my head. I did not have anything on my skin but I would just itching for no reason. Also, I started experiencing heart palpations more than usual. I have some palpations at times but this was more than usual. I have experienced these reactions since then. That was Jan. 29 and today is Feb. 2. Today the itching is better but continue to have heart palpation. I am concerned about taking the 2nd dose of the COVID vaccine Feb. 12. I would like for someone to contact me by phone if any way possible.
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| 55 | 2021-02-01 | chest pain, heart rate increased | Shaking , burning in arm, leg chest face, rapid heart rate |
| 55 | 2021-02-01 | chest discomfort |
The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I wor...
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The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I worked my 12 hour shit. I woke up 300am and my body was hurting so bad, it felt like something was laying on my chest, shoulder arms and legs. I crawled out of the bed and took a Tylenol and that helped a little bit. at 600 am I took another 650 mg Tylenol. And my body has been hurting so bad and I've been itching. I took a bath yesterday about 6:00 and my body is on fire like I'm itching real bad. I don't think I should have took a bath, because that might have made the blood circulate more and my body aches like crazy, worse than before. The last time I took a Tylenol was 6:00.
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| 55 | 2021-02-02 | heart rate increased |
36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morni...
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36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morning, nauseous, chills, hot flashes, racing heartbeat and was very weak. Had some lapses in thought process. I did not have a fever. These symptoms persisted for 5 days. On 2-2-21 I started to get a migraine, so took a prescription medication (Sumatriptan Succinate Tablet 50 mg) and this helped with the nauseousness. My symptoms seem to decrease around 3pm in the afternoon, but never completely go away. Each morning, the cycle repeats with dizziness, nauseousness and chills and some thought lapses. It's been one week since my first dose of the vaccine, and these symptoms are lessening but are still prevalent.
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| 55 | 2021-02-02 | nosebleed |
hives afternoon day of vaccine, next day, stomach ache, fever ( T 100.0) , chills, vomiting, headach...
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hives afternoon day of vaccine, next day, stomach ache, fever ( T 100.0) , chills, vomiting, headache, dizziness, hazy feeling and nosebleed. Symptoms slowly improved over 5 days and returned to work.
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| 55 | 2021-02-03 | palpitations, heart flutter |
About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think an...
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About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
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| 55 | 2021-02-03 | fainting |
CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1...
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CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1/12/21. on 1/13/21 felt near normal. Then 1/14/21 ,almost passed out on way to work,foggy feeling,vertigo,dizzy & therefore called in sick for today,1/14/21. . Vertigo, loss of balance, extreme malaise, near syncopal episodes. . I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes. . 1/20: I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes on 1/15.
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| 55 | 2021-02-03 | chest discomfort, hypertension | Patient BP went very high and experienced chest tightening and shortness of breath |
| 55 | 2021-02-03 | chest pain, chest discomfort, pallor, hypertension |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-04 | fast heart rate |
Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site lim...
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Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site limiting movement, eye pain and blurring. All began approximately 12 hours after vaccination. Did report to the ER at Summit Medical Center 2/3/2021 . Labs were drawn, ekg and cxr done. Md stated all normal. (I had pneumonia and was in a fib upon arrival to Vanderbilt Medical Center when I was admitted there with Covid in March 2020.)
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| 55 | 2021-02-04 | low blood platelet count, platelet count decreased |
petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ...
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petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events
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| 55 | 2021-02-04 | heart rate increased |
racing heart rate around 48 hours after vaccine; Headache for 24 hours (mild); Intermittent shortnes...
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racing heart rate around 48 hours after vaccine; Headache for 24 hours (mild); Intermittent shortness of breath for 48 hours; This is a spontaneous report from a contactable consumer, the patient. This 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 , single dose via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 55 years-old) for COVID-19 vaccination. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included allergy to codeine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown ), dose 1, single dose via an unspecified route of administration in the right arm on 29Dec2020 at 03:45 PM. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any other medication in two weeks. On 19Jan2021 at 05: 00 PM, the patient experienced mild headache for 24 hours and intermittent shortness of breath for 48 hours. On an unknown date, the patient had racing heart rate around 48 hours after vaccine. There was no treatment received for the events. The clinical outcome of events, mild headache and shortness of breath was recovered on an unknown date in Jan2021. The outcome of the event racing heart rate was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 55 | 2021-02-05 | chest pain | Headache, lightheaded, dizziness, bilat foot and arm numbness, chest pain, SOB |
| 55 | 2021-02-07 | hypertension |
1shot on 12/29/2020: 1/9/2021 started to brake out herpes simples on my lips 2nd shot 1/15/2021: 1/...
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1shot on 12/29/2020: 1/9/2021 started to brake out herpes simples on my lips 2nd shot 1/15/2021: 1/16/2021 body and join aches, can barely walk, huge headache, not able to function. The worst lasted 24 hours. 1/17/2021 I felt better : manageable headache, body/join aches almost gone 2/5/2021 very bad headache, vertigo, slept most of the day. 2/6/2021-2/8/21 headache and high blood pressure. 2/8/2021 urgently seeing my PCP
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| 55 | 2021-02-07 | heart rate increased, blood pressure increased |
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127...
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Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
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| 55 | 2021-02-07 | heart rate increased |
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus;...
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Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization. Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120". No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 55 | 2021-02-07 | chest pain |
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C...
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PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
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| 55 | 2021-02-07 | chest pain, chest discomfort |
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib...
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symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
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| 55 | 2021-02-08 | palpitations, chest discomfort |
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running co...
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A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
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| 55 | 2021-02-08 | palpitations |
Received second vaccine on 2/5/21 and woke up the next morning with HA, body aches, chills, nausea, ...
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Received second vaccine on 2/5/21 and woke up the next morning with HA, body aches, chills, nausea, and palpitations. Went to ER on 2/6/21.
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| 55 | 2021-02-09 | heart rate increased |
Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited;...
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Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown. Information on Lot/batch number has been requested.
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| 55 | 2021-02-10 | heart rate increased |
6 days after first covid vaccine I ended in the ED with a mild heart attack and a spot on lungs for ...
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6 days after first covid vaccine I ended in the ED with a mild heart attack and a spot on lungs for possible pneumonia. Tests ran showed no blockage or issue with heart and no blood clot found. Tests are still being run, but no cholesterol issues, low BP rate always, and no history of heart issues for myself or family members. 2nd dose caused shortness of breathing starting at 24 plus hours and increased heart rate for 7+ days and starting to decrease. Lungs cleared up after 6 days from 2nd dose.
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| 55 | 2021-02-10 | chest discomfort | Pressure in chest, shortness of breath |
| 55 | 2021-02-10 | lightheadedness |
Within 15-minutes of vaccination, the patient reported feeling dizzy and near-syncopal. EMS monitore...
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Within 15-minutes of vaccination, the patient reported feeling dizzy and near-syncopal. EMS monitored the patient's condition on-site.
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| 55 | 2021-02-10 | heart rate increased, fast heart rate |
after about an hr i started to get shortness of breath and heart tachycardia, i felt like i was run...
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after about an hr i started to get shortness of breath and heart tachycardia, i felt like i was running. it lasted about two hrs. heart rate stayed in the 90s and its usually in the 60s for about an hour
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| 55 | 2021-02-11 | chest discomfort |
Client arrived back to the clinic location an hour after her vaccination and c/o chest tightness. Sh...
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Client arrived back to the clinic location an hour after her vaccination and c/o chest tightness. She verbalized feeling fine after waiting 15 mins at our observation area outside and felt her adverse effect while at home. She used her Albuterol inhaler at home and verbalized some congestion as well as feeling unwell since last Thursday. V/S taken and are as follows: BP 132/84, HR 85, R 20, O2 99%. Lungs were clear upon auscultation and no SOB noted. Client has HX of chest tightness and allergic reactions to certain foods. Client was advised to go to the ER for evaluation in which she stated that she would like to stay at our clinic site until she felt some relief. After 15 mins, the client stated the chest tightness was subsiding and she was ready to go home. Client was again advised to get evaluated at the ER (the client verbalized that she would do so if her chest tightness recurred)and to have a companion accompany her in which her daughter was able to do so. The client and her daughter left the clinic site approximately at 1645.
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| 55 | 2021-02-14 | palpitations |
After client received vaccine client states that her heart was racing. Vital signs obtained by EMS....
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After client received vaccine client states that her heart was racing. Vital signs obtained by EMS. Vital Signs BP 120/74, Pulse 100, O2 sat 99%. Client states she fees better Client discharged home by EMS.
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| 55 | 2021-02-14 | body temperature decreased |
Severe chills on 2/12/21; overnight on 2/12/21 restless sleep; 2/13/21 - headache, stomachache, diar...
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Severe chills on 2/12/21; overnight on 2/12/21 restless sleep; 2/13/21 - headache, stomachache, diarrhea, vomiting, chills, temperature of 95.6
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| 55 | 2021-02-15 | palpitations | Felt week, trembling, felt like passing out, palpitations, bp 144/98, pulse 96 |
| 55 | 2021-02-16 | chest pain | Slight burning in my chest x approximately 7-10 minutes |
| 55 | 2021-02-17 | chest discomfort |
anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A ...
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anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation. Medical history included severe peanut allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy. She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021. She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-02-18 | fainting |
About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling...
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About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling dizzy/ready to faint, unable to sleep, extreme exhaustion, general over all weakness lasting about 6-days.
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| 55 | 2021-02-18 | blood pressure increased |
Patient experienced an episode of vertigo, sudden increase in blood pressure, and feeling anxious. P...
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Patient experienced an episode of vertigo, sudden increase in blood pressure, and feeling anxious. Patient had similar episodes at prior vaccinations.
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| 55 | 2021-02-23 | pallor, lightheadedness, chest discomfort |
Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am ,...
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Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am , IV fluids administered, IV Ephedrine administered, EKG, telemetry monitor Taken to ER ,
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| 55 | 2021-02-24 | pallor |
COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 m...
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COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 min later, pt stuck her head out of the doorway of her room to notify LPN that she was feeling lightheaded. LPN went to pt's room to assess. Patient laid back in exam chair. Patient mask removed. Color palor. Skin clammy, Vitals obtained, patient reports tingling in arms, legs, and feet. Patient vitals 96/67. Provider at door for eval and advised EMS notification. Patient vitals monitored. 20G IV placed at 1358 left forearm by RN x1 NSL. Color begins to return. Patient tilted back up in chair, vitals obtained and WNL. At 1423 patient stood up with stand by assistance, placed mask on herself and reports does not feel can stand at this time. Patient A&O x4. Reports lightheadedness and dizziness. Patient asks what she is to do about her second vaccine and was advised that she needs to consult with her PCP. Pt states will take Benadryl. Pt again advised to check with her PCP before having second dose or taking Benadryl with second dose. Patient advised per EMS to bring second person with for transport if cleared to receive second dose. At 1428 reports no lightheadedness or dizziness with standing. At 1429 patient ate three PB crackers with water. At 1432 patient ambulatory in halls with Medic staff by side. At 1434 back to room, reports 95% better with head, tinglining in feet and hands 90% improvement. At 1445 vitals WNL patient A&O x4. At 1449 IV pulled by RN. At 1452 patient discharged to home per self.
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| 55 | 2021-02-24 | atrial fibrillation, arrhythmia | Cardiac dysrhythmia. Paxoxsymal A-fib, atrial tachycardia. |
| 55 | 2021-02-24 | chest pain |
Large area of swelling around injection site about the size of a softball measuring 14 cm in diamete...
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Large area of swelling around injection site about the size of a softball measuring 14 cm in diameter. Treatment- anti-inflammatories- ibuprofen. It has now been 1 week and is down to 4 cm. Also, on 2/23 had a flair-up of the post CoVid syndrome and ended up in the ER with chest pain and severe shortness of breath. All cardiac tests came back within normal limits. Chest X-ray just showed atelectasis in bases remaining from bilat CoVid pneumonia 3 months ago. Diagnosis was post CoVid syndrome. Treatment - nebulizer and anti-inflammatories - more ibuprofen. Returned to baseline shortness of breath that has existed since having CoVid in November in about 8 hours. I'm not sure if this was a reaction to the vaccine, but thought I would include it.
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| 55 | 2021-02-24 | palpitations |
Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen ...
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Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen level 99% on room air. EMS at patient's side at clinic, evaluated and discussed symptoms with patient. No interventions needed at this time and patient monitored for an additional 15 mins. VS remain stable and at 1045a, BP was 142/76, oxygen level 100%, HR 58 with patient states feeling better and feels she can drive home. EMS released patient.
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| 55 | 2021-02-25 | hypertension | Broke out in hives on my back and blood pressure was very high |
| 55 | 2021-02-25 | palpitations |
Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patie...
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Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patient given Epinephrine 0.3 IM, Benadryl 50 MG IM, and Solumedrol 62.5 mg IM and then sent to ER.
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| 55 | 2021-02-25 | palpitations |
Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observat...
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Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observation, reported feeling better.
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| 55 | 2021-02-28 | palpitations |
Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 w...
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Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
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| 55 | 2021-02-28 | deep vein blood clot | severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room. |
| 55 | 2021-03-02 | chest pain |
Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of ...
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Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of shortness of breath, chest pain, and weakness. Had some burning in the left, upper chest. Vital signs were stable throughout episode. EMS onsite. Baseline EKG normal. Patient requested transport to ED. Transported via EMS.
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| 55 | 2021-03-02 | heart rate increased, hypertension | Spiked blood pressure 187/157. Rapid pounding heart heaviness in chest nausea jittery dizziness |
| 55 | 2021-03-03 | chest discomfort | chest tightness. some wheezing. |
| 55 | 2021-03-04 | chest pain | dizziness and chest pain. Evaluated by EMS-Cleared |
| 55 | 2021-03-07 | chest discomfort |
C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck ...
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C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck and numbness of neck and jaw with extension from her ear to nose. Felt some tightening of chest on 3/4/21 at noon. took benadryl. Majority of numbness subsided on Friday 3/5 however still having numbness at hairline on opposite side of face.
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| 55 | 2021-03-08 | chest pain |
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate...
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Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
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| 55 | 2021-03-08 | chest discomfort |
headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administra...
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headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administration
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| 55 | 2021-03-09 | chest discomfort |
1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm...
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1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm, fatigue and headache. Took tylenol several time through the day and fever resolved approx 7pm on 1/8/21. Approx 11:00pm that day I woke up dizzy and felt chest heaviness, but went back to sleep. Woke up again after midnight and sat up in bed and felt like I was falling out of the bed (extremely dizzy) and decided to check my oxygen level due to me having prn shortness of breath since contacting covid in July 2020 and noticed that my heart rate was 186 bpm. Went to ER and MD was told that I had a covid shot the she wasn't sure if that what caused the SVT and could not tell me if I should or shouldn't take injection #2. Injection #2-(1/29/21) 4 hours after taking this injection started with low grade temp, sore arm and achy all over and noticed my heartrate was in the 120's. Woke up next morning temp was 103.0. Took tylenol troughout day and that day. Heart rate was in the upper 150's. I did not go to the ER. The next day heart rate continues 140-150.
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| 55 | 2021-03-10 | heart attack |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-11 | palpitations |
arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starti...
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arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starting racing & my throat felt swollen I didn't seek medical treatment because I have an epi pen in my house ( i have a granddaughter allergic to peanuts) I went to bed, woke up around 4am heart racing & swollen throat were gone
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| 55 | 2021-03-14 | hypertension, fast heart rate |
Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis pr...
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Immediate tachycardia, tingling in throat and mouth, hypertension. Treatment in ER. Anaphylaxis protocol. Days later nausea w dizziness. By day 6 sudden onset of vertigo, diagnosed as vestibular neuritis. PT, supportive meds, continued dizziness.
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| 55 | 2021-03-14 | chest pain, lightheadedness | chest pain and nearsyncope 3/13 |
| 55 | 2021-03-15 | fainting | Numbness in arm, fainting, nausea for a thirty minute period. Treated in emergency room for nausea |
| 55 | 2021-03-15 | lightheadedness |
Patient experienced near syncope after vaccination. Lasted less than 5 minutes. No cardiac symptoms....
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Patient experienced near syncope after vaccination. Lasted less than 5 minutes. No cardiac symptoms. No Resolved with orange juice as patient had not had PO intake for longer than 12 hours prior to vaccination.
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| 55 | 2021-03-15 | chest discomfort |
Shortly after leaving, the patient said that she began to feel very warm; she also said that her thr...
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Shortly after leaving, the patient said that she began to feel very warm; she also said that her throat felt itchy. She went to the store to buy some medication, but then noticed that she was diaphoretic, and she had pressure in her upper chest and neck. She presented to the ER with these symptoms.
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| 55 | 2021-03-15 | blood pressure increased, heart rate increased |
Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, ...
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Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, Vivid Dreams, feeling out of it, increased pulse 110, increased blood pressure 160/80 not a hypertensive patient, dizziness and light headedness. Increase vitals day 2 Back pain started late in the 2nd day and ended on 3/16.
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| 55 | 2021-03-16 | low blood oxigenation |
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v...
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4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
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| 55 | 2021-03-17 | palpitations |
Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 m...
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Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 minutes with rest. No uticaria, dyspnea, weakness. Pt departed after 15 additional minutes
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| 55 | 2021-03-17 | loss of consciousness |
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain inte...
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pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-03-18 | pallor |
PT WENT PALE AND FELT FAINT AND NAUSEOUS FOR SEVERAL MINUTES. SHE RECLINED AND ELEVATED HER FEET FOR...
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PT WENT PALE AND FELT FAINT AND NAUSEOUS FOR SEVERAL MINUTES. SHE RECLINED AND ELEVATED HER FEET FOR SEVERAL MINUTES. SHE SIPPED WATER AND GINGER ALE AND FELT BETTER AFTER A FEW MINUTES
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| 55 | 2021-03-20 | heart rate increased, blood pressure increased |
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in...
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A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
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| 55 | 2021-03-20 | blood pressure increased, chest discomfort, heart rate increased |
pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and d...
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pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and dizzy. after recovering from the light headedness she stood up and complained of chest tightness and difficulty breathing, ems stated blood pressure increased and heart rate as well. she complained of a shakey feeling. she was sent on ambulance to the hospital after 45 minutes in EMS tent.
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| 55 | 2021-03-21 | chest discomfort |
Presented w/ c/o feeling lightheaded and chest tightness, hands sweaty. B/P 126/67, HR 104, O2 sat ...
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Presented w/ c/o feeling lightheaded and chest tightness, hands sweaty. B/P 126/67, HR 104, O2 sat 99%. 5:09 pm B/P 122/71, HR 106, ECG strip NSR. 5:25 pm Palms dry HR decreased to 98, stated lightheadedness subsided. States she gets anxious and just wanted to be checked. Advised if symptoms returned, pull over safety and call 911. Said she was going home to relax w. hot bath and sit on patio.
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| 55 | 2021-03-21 | nosebleed |
nose bleed that started after vaccine. no prior history of nose bleed bleeds steadily for approxima...
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nose bleed that started after vaccine. no prior history of nose bleed bleeds steadily for approximately then 30 min then faintly for hours
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| 55 | 2021-03-22 | chest discomfort |
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ...
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- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
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| 55 | 2021-03-22 | chest discomfort |
Nausea started around 12:30pm 3/22/21, lasted for up to 6hrs Tightness in chest around 1:40pm 3/22/2...
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Nausea started around 12:30pm 3/22/21, lasted for up to 6hrs Tightness in chest around 1:40pm 3/22/21 lasted for about 2.5hrs
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| 55 | 2021-03-22 | fainting |
Patient alerted staff to feeling lightheaded. Assisted to chair, BP 80/50, slightly diaphoretic. P...
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Patient alerted staff to feeling lightheaded. Assisted to chair, BP 80/50, slightly diaphoretic. Patient experienced syncopal episode. 911 called. Patient awake, alert, conversant within approx. 3-5 minutes.
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| 55 | 2021-03-23 | anaemia |
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around...
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3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
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| 55 | 2021-03-23 | chest discomfort, deep vein blood clot, fibrin d dimer increased, chest pain, pulmonary embolism |
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ...
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Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
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| 55 | 2021-03-23 | chest discomfort, hypertension |
Tightness in chest, difficulty breathing, hypertensive, headache, 4 lead showed normal sinus rhythm,...
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Tightness in chest, difficulty breathing, hypertensive, headache, 4 lead showed normal sinus rhythm, repeat blood pressure showed 180/100, Patient transported to hospital ER. 178/106, 68, 16, 100 % RA, BS 214
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| 55 | 2021-03-23 | fast heart rate, heart rate increased, arrhythmia |
Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spont...
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Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in the left arm on 19Jan2021 16:15 as a single dose for covid-19 immunisation. The patient's medical history included supraventricular tachycardia (SVT), atrial fibrillation (Afib), atrial flutter, colon cancer, endometrial cancer, Lynch Syndrome, asthma, osteoarthritis, lung nodules being watched, kidney cysts, obesity and enlarged liver all from unknown date. Concomitant medications included metoprolol tartrate; alprazolam; acetylsalicylic acid (ASPIRIN LOW); ascorbic acid (VIT C); and colecalciferol (VIT D3). The patient previously took epinephrine and experienced sensitivity (reported as (sensitive to epinephrine due to heart arrytmia). The patient received the first dose of bnt162b2 (lot:ELI284) on 29Dec2020 in the left arm for covid-19 immunization. On 19Jan2010 at 16:15, the patient experienced within the first minute or two, she felt her heart rate start to race. She used Kardia device to check it and she was in Tachycardia at 16:15. The patient mentioned that she carry device with her since she have a history of SVT, Atrial Flutter, and AFib, with prior ablations. Patient was pretty familiar with what Tachycardia feels like so she was pretty sure she was not having an allergic reaction to the vaccine, but rather the vaccine had triggered her heart arrhythmia. After continuing to monitor her HR, for approx. 20 minutes, and it continued to stay at 135 -145, the doctor who had administered the vaccine took her to the local hospital to have her evaluated. The patient received this vaccine at the facility where she was employed. The outcome of the events was recovered on an unspecified date in 2021.
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| 55 | 2021-03-23 | lightheadedness | Vasovagal symptoms, EMS treated patient |
| 55 | 2021-03-24 | chest pain |
After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in...
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After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in lower back and progressed to mid/upper back, sides and under front ribcage over the next 6 days. Muscle spasms accompanied back pain. I had a fever of 99.9 as well. Fever broke on 3/25/21 and pain has started to lessen somewhat on this date. This is by far the worst back pain I've ever experienced and was very strange in that it moved from lower to mid back over the course of 5 days. I've never had back spasms before.
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| 55 | 2021-03-24 | heart rate irregular |
Dizziness and fatigue on the day of the injection. Next morning woke at 4 AM to vomiting diarrhea fe...
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Dizziness and fatigue on the day of the injection. Next morning woke at 4 AM to vomiting diarrhea fever of 100° delusional soreness and terrible headache. Also suffered irregular heartbeat and breathlessness
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| 55 | 2021-03-24 | chest discomfort |
Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 ...
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Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 hours but headache lasted until next day.
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| 55 | 2021-03-25 | chest discomfort |
55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for...
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55 yo female received first dose of the Pfizer COVID-19 vaccine on 3/17 at 1309. Pt was observed for 15 minutes without any symptoms. She left the facility, but returned a few minutes later with complaints of dizziness, nausea, thick tongue, and itching palate. Upon assessment, vitals were BP 145/83, HR 83, SpO2 99%. Given diphenhydramine 25 mg solution. Shortly thereafter, pt experienced increasing tongue thickness and chest tightness. Epinephrine 0.3 mg auto injector administered followed by famotidine 20 mg and hydrocortisone 100 mg. Continued dizziness, ear ringing, SpO2 83%. EMS called and patient transferred to the ED. Presented to the ED without symptoms and observed for 4 hours. Discharged home with...
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| 55 | 2021-03-25 | heart rate increased, blood pressure increased |
INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE A...
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INCREASE IN BLOOD PRESSURE 50 POINTS, AND INCREASE IN HEARTRATE 30 POINTS IN FIRST 30 MINUTES SORE ARM AT INJECTION SITE DAY 2, FATIGUE DAY 2, NAUSEA AND EASILY DEHYDRATED DAY 2-5 SWOLLEN LYMPH NODES DAY 8-10 ON RIGHT SIDE ONLY
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| 55 | 2021-03-25 | chest pain |
Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pai...
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Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pain, peripheral vascular prominence fatigue unilateral muscle cramp.back pain exacerbation and return of migraine headaches resolved after hysterectomy.
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| 55 | 2021-03-25 | heart attack | STEMI, ventricular fibrillation decreased ejection fraction to 30% |
| 55 | 2021-03-26 | heart rate increased, hypertension |
0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK O...
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0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK OF THE HEAD. PT STATED A HISTORY OF GETTING H/A. MONITORING V.S. WATER OFFERED REFUSED HAD BREAKFAST. 0810-02 SAT 99% 0812 HR 68 0815 BP 142/82-SAT 99% RR 20 HR 65 0824 99% RR 20 HR 67 0825 BP- 112/78 RR 16 Patient felt well enough to leave
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| 55 | 2021-03-26 | chest discomfort |
A few minutes after the injection patient developed left eye itching and throat scratchiness (approx...
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A few minutes after the injection patient developed left eye itching and throat scratchiness (approximately 0905). Vitals at 0913: 104/74 BP, 74 HR, 98.3 temp, 100 % oxygen saturation. Gave 50 mg oral Benadryl at 0916. Vitals at 0918: 100 % oxygen saturation, 111 HR, 133/71 BP, chest heaviness noted at this time. Vitals as of 0923: 114 HR, 100 % oxygen saturation, 122/83 BP. Patient transported to Emergency Room.
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| 55 | 2021-03-26 | hypertension |
Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal...
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Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
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| 55 | 2021-03-28 | fainting | Pt syncopal, diaphoretic |
| 55 | 2021-03-30 | heart attack, inflammation of the heart muscle |
Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported...
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Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported feeling myalgia, diarrhea, and body aches and chills. The patient presented to the ED and was admitted with myocarditis and NSTEMI. Left heart cath did not show evidence of epicardial coronary artery disease. The patient was discharged from the hospital after receiving fluid resuscitation and supportive care. The patient returned to the ED with worsening myocarditis and was found to be in cardiogenic shock requiring vasopressor support. The patient developed VT storm and was intubated and sedated. The patient is currently in the ICU and remains intubated and sedated
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| 55 | 2021-03-30 | chest pain |
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec...
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Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
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| 55 | 2021-03-31 | chest pain |
I am not sure if this is from the vaccine or not, but ever since I received the second dose of the v...
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I am not sure if this is from the vaccine or not, but ever since I received the second dose of the vaccine I have had alot of GI issues. Chest pain, belching, inflammation in throat, headaches, body aches, weight loss, fatigue.
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| 55 | 2021-04-01 | cerebrovascular accident, blood pressure increased |
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al...
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her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
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| 55 | 2021-04-06 | deep vein blood clot |
I began developing pain in my left leg Friday, March 19th - two days after receiving my second injec...
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I began developing pain in my left leg Friday, March 19th - two days after receiving my second injection. My early Monday morning I was in so much pain that I went to the ER. I was diagnosed with acute DVT in my entire left leg from the Iliac vein in my abdomen down to the ankle. The entire leg was occluded.
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| 55 | 2021-04-06 | chest discomfort |
felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Ups...
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felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
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| 55 | 2021-04-09 | chest discomfort |
in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightne...
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in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.
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| 55 | 2021-04-09 | fainting |
must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-ye...
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must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-04-13 | cerebrovascular accident, cerebral haemorrhage |
That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER an...
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That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER and they initially thought I had bells palsy, but after a CT to confirm they found a brain bleed and I was rushed to hospital and put in the ICU and after two MRI's they also found a stroke - I had several tests and stayed in ICU for 5 days they could never determine the cause of the brain bleed or stroke - all tests were negative for autoimmune diseases.
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| 55 | 2021-04-14 | chest discomfort |
55 YEAR OLD FEMALE REPORTED TIGHTNESS IN CHEST AND HEADACHE ABOUT 30 MINUTES AFTER VACCINATION. ON ...
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55 YEAR OLD FEMALE REPORTED TIGHTNESS IN CHEST AND HEADACHE ABOUT 30 MINUTES AFTER VACCINATION. ON SITE EMS RESPONDED, VITALS BELOW. SHE WAS MONITORED AND RELEASED TO HOME.
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| 55 | 2021-04-14 | blood pressure decreased |
Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Pa...
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Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Patient had her own Benadryl and self administered 25 mg. orally. Swelling began to decrease and BP lowered as well. No presence of hives or SOB. Per Fire Rescue no further evaluation needed. Client released at 12:00pm.
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| 55 | 2021-04-14 | chest pain | Metallic taste in mouth, chest pains |
| 55 | 2021-04-15 | heart rate increased, fast heart rate, atrial fibrillation |
First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot sam...
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First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot same fast heartbeat seemed to subside but I was tired. Next day it felt as if someone threw a fast pitch softball at my chest took my breath away seemed to last several minutes then extreme heartburn set in. Very fatigued, heart burn lasted 9 days. Starting on 4/5/21 joint pain also started in my new hip. On 4/12/21 jaw pain set in at which point went to urgent care.
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| 55 | 2021-04-16 | cerebrovascular accident |
On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my v...
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On April 9th, I developed a headache at 9pm while watching tv. About 15 minutes later I noticed my vision was changing so I called my daughter to come stay with me and took tylenol fast release capsules. I went to bed and woke up the next morning with the same headache so I asked my daughter to take me to urgent care. Upon arrival they did a Covid test. I told them about my previous stroke in July 2020 and that I had a PFO closure done in October and have been on Plavix (clopidogrel) since then so I wasn't worried about stroke. The dr sent me to the ER immediately and they performed an MRI scan and told me I had suffered a new stroke due to blood clot.
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| 55 | 2021-04-18 | fainting |
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt ...
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I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-04-23 | heart rate increased |
fever at 102.6; Heart Rate 103; muscle/big joint pain; muscle/big joint pain; This is a spontaneous ...
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fever at 102.6; Heart Rate 103; muscle/big joint pain; muscle/big joint pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:30 (Batch/Lot Number: EL9265) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. Medical history included Type 2 Diabetes. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021, 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Known allergies was None. It was reported that the patient had fever at 102.6 Heart Rate 103, muscle/big joint pain 12th hr after 2nd dose on 09Feb2021 10:00 PM (22.00). fever reduced to 99.9F heart Rate 72 by 36th hr after vacinned, no muscle/joint pain temperature 98.6, heart rate 62 by 48 hr after. temperature 97.9 heart rate 66 by 72 hr after. No treatment received for AE. Outcome of the events was resolved in Feb2021.
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| 55 | 2021-04-24 | heart rate increased |
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ...
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felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
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| 55 | 2021-04-25 | cerebrovascular accident, blood clot |
5 days after I had the second dose of the Pfizer Covid vaccine, I had blood clots that caused severa...
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5 days after I had the second dose of the Pfizer Covid vaccine, I had blood clots that caused several strokes. I have normal cholesterol, normal blood pressure, normal A1C and other diabetes measures, and my blood was tested for multiple things to identify what caused the clotting. Every single test came back within normal limits. The ONLY thing that changed was that vaccine. And it was 5 days after the second dose. The doctors cannot figure out why I had a stroke.
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| 55 | 2021-04-26 | chest pain |
this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burn...
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this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs. The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
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| 55 | 2021-04-29 | hypertension |
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 1...
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Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
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| 55 | 2021-05-05 | chest pain |
low-grade temperature Fatigue Shortness of breath Wheezing Asthma with acute exacerbation Pneumonia ...
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low-grade temperature Fatigue Shortness of breath Wheezing Asthma with acute exacerbation Pneumonia due to COVID-19 virus Chest Pain prednisone azithromycin
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| 55 | 2021-05-07 | hypertension, fast heart rate |
Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood press...
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Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood pressure. Pulse was 160, Blood pressure around 182/111. Ambulance came and took me to a local hospital; I felt I like I was going to faint; I felt light headed; I feel anxiety; My breathing was like shallow; I had to take deep breath to prevent myself; Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood pressure. Pulse was 160, Blood pressure around 182/111. Ambulance came and took me to a local hospital; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 24Apr2021 at 15:00 (at the age of 55 years-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing Type II diabetes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Ciprofloxacin , food allergy from an unknown date and unknown if ongoing known allergies: tomatoes , rubber sensitivity from an unknown date and unknown if ongoing known allergies: latex. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), dose 1 in the right arm on 31Mar2021 at 3:00 PM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin 2,000 mg daily taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) .75 mg /0.5 ml taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported and doxycycline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced amlodipine and lisinopril also taken daily within 30 seconds, I got tachycardia, my heart started beating quite fast, faster my pulse and it was 160 beat per minute and high blood pressure, pulse was 160, blood pressure around 182/111. The ambulance came and took me to a local hospital (tachycardia) (hospitalization) on 24Apr2021 at 15:00. I felt I like I was going to faint; I felt light headed on an unspecified date, I feel anxiety on an unspecified date, my breathing was like shallow; I had to take deep breath to prevent myself on an unspecified date. An emergency room visit was required for tachycardia, high blood pressure, faint and light headed, breathing shallow and anxiety. The patient underwent lab tests and procedures which included blood pressure measurement: 182/111 mmhg on 24Apr2021, heart rate: 160 on 24Apr2021. The patient had blood work done a few weeks ago, albumin, thyroid stimulating hormone (TSH), Vitamin-D, cholesterol and complete blood count (CBC) (Further not clarified). Therapeutic measures were taken as a result of amlodipine and lisinopril also taken daily within 30 seconds, it got tachycardia and high blood pressure, pulse was 160, blood pressure around 182/111, ambulance came and took me to a local hospital (tachycardia and hypertension), felt I like I was going to faint; I felt light headed (dizziness), I feel anxiety (anxiety), my breathing was like shallow and I had to take deep breath to prevent myself (hypopnoea) and included intravenous (IV) hydration and blood pressure medication. The clinical outcome of tachycardia and high blood pressure was recovering and unknown for faint and light headed, breathing shallowand anxiety. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number is available; further information has been requested.
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| 55 | 2021-05-07 | blood clot |
Blood clot, inner right upper leg; Chills; stomach upset; nausea; headache; This is a spontaneous re...
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Blood clot, inner right upper leg; Chills; stomach upset; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:30 (Batch/Lot Number: Er8735) as single dose for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced blood clot in inner right upper leg, chills, stomach upset, nausea, and headache on 01Apr2021 at 20:00. The events were not treated. The patient was not tested for covid post vaccination. The patient had the second dose on 22Apr2021 at 11:30 AM in the left arm (lot: Er8731). The outcome of the events was recovered with sequel. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-05-10 | palpitations |
Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every othe...
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Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every other day the 3rd week. Pains in legs.
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| 56 | 2020-12-31 | palpitations |
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m...
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Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
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| 56 | 2021-01-01 | hypertension, chest discomfort |
headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), ch...
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headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), chest tightness
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| 56 | 2021-01-03 | heart rate increased |
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd...
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They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
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| 56 | 2021-01-05 | fast heart rate |
Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from ...
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Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue
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| 56 | 2021-01-05 | vaginal haemorrhage |
started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initi...
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started spotting this morning; low back pain mild; breast tenderness; abdominal pain mild; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 30Dec2020 this case now contains all required information to be considered valid. A contactable nurse (patient) reported a 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), intramuscular on the left deltoid on 17Dec2020 at SINGLE DOSE for COVID-19 vaccination at the hospital, estradiol (ESTRADIOL gel), oral from May2020 and ongoing at 1 mg, 1x/day for menopause and progesterone (PROGESTERONE tablet), oral from May2020 and ongoing at 100 mg, 1x/day for menopausal symptoms. Medical history included blood pressure issues since 2000 and ongoing. The patient was also menopausal (ongoing). Concomitant medication included losartan (LOSARTAN) for blood pressure issues. On 28Dec2020, the patient experienced abdominal pain mild. She also had low back pain mild and breast tenderness noted on 29Dec2020. The patient also stated that she felt like she was going to have a period even she has not had a period in 3 years as she was on progesterone and estradiol. The patient will see doctor to make sure that it was not anything. On 30Dec2020, the patient reported that she started spotting this morning. The patient did not receive any treatments for the events. The action taken in response for progesterone and estradiol as dose not change. The patient recovered from abdominal pain mild on 28Dec2020; low back pain mild and breast tenderness on 29Dec2020. Stated that the spotting resolved at noon on 30Dec2020. The reporter considered the events as non-serious. The reporter also considered that the events were related to Pfizer BioNTech Vaccine while unrelated to estradiol and progesterone.
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| 56 | 2021-01-06 | pulse abnormal, chest pain |
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw...
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C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
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| 56 | 2021-01-06 | loss of consciousness |
Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunc...
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Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.
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| 56 | 2021-01-06 | fast heart rate, chest discomfort |
Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having ...
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Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having tachycardia hr in the 110s, fullness feeling to head, chest irritation. Went to ER, discharged same day. On drive home she started having bilateral lower extremity weakness and felt super sleepy. 01/01/21 symptoms resolved. 01/02/21 woke up with chills at 2am, went back to sleep, woke back up at 5 am same day and symptoms resolved. 01/03/21-mild headache-took Tylenol sinus-headache resolved. Pt. states that she has felt fine ever since.
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| 56 | 2021-01-06 | fainting | SkinRash, CoughWheeze & Syncope |
| 56 | 2021-01-07 | chest discomfort | 35 minutes After vaccination.... complaints of chest tightness, "funny" tongue |
| 56 | 2021-01-07 | heart rate increased, chest discomfort |
48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after rece...
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48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.
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| 56 | 2021-01-07 | palpitations |
Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevat...
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Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevation on EKG in ER, taken to Cath Lab- no intervention done. D/C home 12/22/20. Previous Hx of COVID per patient
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| 56 | 2021-01-07 | chest pain |
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG...
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HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
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| 56 | 2021-01-07 | palpitations |
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/...
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Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
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| 56 | 2021-01-07 | oxygen saturation decreased |
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27...
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Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
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| 56 | 2021-01-07 | heart rate increased, blood pressure increased |
Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. ...
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Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. O2 100% RA. Patient provided with snacks and water. Status monitored during observation of 30 mins. All symptoms resolved at discharge from vaccine clinic.
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| 56 | 2021-01-07 | hypotension |
Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi...
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Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi at vax site. Taken to ED from vax site. Started on epi drip. Admitted to SHC.
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| 56 | 2021-01-07 | hypertension |
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t...
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The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
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| 56 | 2021-01-08 | chest pain |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-08 | palpitations |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-09 | palpitations |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-10 | palpitations |
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. A...
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Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
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| 56 | 2021-01-10 | heart rate increased |
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ...
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feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
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| 56 | 2021-01-11 | blood pressure increased |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | chest pain |
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes...
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Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
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| 56 | 2021-01-11 | heart rate increased | chills, elevated heart rate, headache, Sore Arm |
| 56 | 2021-01-12 | hypotension |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | chest discomfort |
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai...
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Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
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| 56 | 2021-01-13 | palpitations, heart rate increased | Chest palpitations and fast heart rate (99); rested and symptoms decreased |
| 56 | 2021-01-13 | blood pressure increased | Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own |
| 56 | 2021-01-13 | blood pressure increased, heart rate increased |
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT...
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PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
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| 56 | 2021-01-13 | palpitations |
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ...
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The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
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| 56 | 2021-01-13 | palpitations |
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ...
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Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
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| 56 | 2021-01-14 | very slow heart rate | Fever chills fatigue arm pain upset stomach bradycardia |
| 56 | 2021-01-14 | platelet count decreased, low platelet count | mild rhabdomyolysis presentation and lymphopenia and thrombocytopenia |
| 56 | 2021-01-16 | loss of consciousness |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-17 | lightheadedness, pulse abnormal, loss of consciousness |
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob...
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Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
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| 56 | 2021-01-18 | fast heart rate, blood pressure increased |
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma...
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1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
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| 56 | 2021-01-18 | fainting |
Headache, upper back and neck pain, chills, nauseated, dizzy. Patient woke up this morning to use th...
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Headache, upper back and neck pain, chills, nauseated, dizzy. Patient woke up this morning to use the bathroom and had a syncopal episode with no known injury.
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| 56 | 2021-01-18 | chest pain | sore arm chest pains began on friday December 25th |
| 56 | 2021-01-19 | hypotension |
Patient reports experiencing hypotension with blood pressure of 55/39. The onset was 12 hours after ...
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Patient reports experiencing hypotension with blood pressure of 55/39. The onset was 12 hours after receiving the booster. Patient reports the symptoms lasted 12 hours.
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| 56 | 2021-01-19 | hypotension |
Patient reports experiencing hypotension, with blood pressure to 55/39. The onset was 12 hours after...
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Patient reports experiencing hypotension, with blood pressure to 55/39. The onset was 12 hours after receiving the booster dose with the symptom lasting 12 hours.
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| 56 | 2021-01-19 | chest pain |
Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that s...
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Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that she woke up from a nap around 1500 hours with constant, midsternal chest pain. Chest pain is non-exertional, non-pleuritic, and non-radiating. She states chest pain is exacerbated by certain movements. Patient endorses lightheadedness.
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| 56 | 2021-01-19 | chest pain, fast heart rate |
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination....
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Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
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| 56 | 2021-01-19 | chest pain |
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7...
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acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
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| 56 | 2021-01-19 | chest discomfort, blood pressure increased |
at 1:36pm client started c/o heaviness in chest, denies SOB.Client had taken Benadryl 50mg po and 2 ...
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at 1:36pm client started c/o heaviness in chest, denies SOB.Client had taken Benadryl 50mg po and 2 Zyrtec at 12:30pm to offset a reaction. Bp was elevated. Taken to triage area. no medications given. 2:35 pm client reports improvement is chest heaviness. Her husband was with her to drive her home.
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| 56 | 2021-01-20 | atrial fibrillation, heart rate increased |
On the evening that the recipient received the vaccine, heart rate increased for two hours, at one p...
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On the evening that the recipient received the vaccine, heart rate increased for two hours, at one point climbing to 140 beats per minute. Her Apple Watch detected atrial fibrillation. The atrial fibrillation resolved after two hours.
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| 56 | 2021-01-20 | fainting |
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mil...
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Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
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| 56 | 2021-01-20 | palpitations | chills, sore arm, heart racing loss of appetite |
| 56 | 2021-01-21 | atrial fibrillation, palpitations |
I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with...
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I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with RVR. Heart rate 166 upon arrival to the ED.
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| 56 | 2021-01-22 | heart rate increased, blood pressure increased |
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was e...
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At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air. From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
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| 56 | 2021-01-22 | palpitations |
Heart palpitations dizziness /or lightheadedness Assisted to reclining chair vitals done and norma...
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Heart palpitations dizziness /or lightheadedness Assisted to reclining chair vitals done and normal. Rested about 20 more minutes and fine.
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| 56 | 2021-01-23 | palpitations | Heart racing from 9 AM all day, ranging from 110 to 148. My normal is 65 at rest. |
| 56 | 2021-01-23 | palpitations |
fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area larg...
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fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area large where swelling was and migrating to feet and experiencing dizziness, heart is racing; gasping for air over phone but able to speak a complete sentences
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| 56 | 2021-01-24 | fainting |
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started f...
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2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better. Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator. Had presyncopal aura, then fainted. Apparently fell on buttocks, which are sore. No other symptoms. Constitutional symptoms have resolved. Evaluated in ED today.
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| 56 | 2021-01-24 | chest pain |
Patient informed medic while sitting in the observation area that she was experiencing chest pain, d...
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Patient informed medic while sitting in the observation area that she was experiencing chest pain, difficulty breathing and throat tightness. Patient was taken to medic area vs=179/89, pulse 121, o@ sat 99%
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| 56 | 2021-01-24 | fast heart rate, palpitations | Tachycardia pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration) |
| 56 | 2021-01-25 | chest discomfort |
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ...
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The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
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| 56 | 2021-01-25 | blood pressure increased |
Within two hours of the second dose, I experienced a severe headache. It has been two weeks since ...
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Within two hours of the second dose, I experienced a severe headache. It has been two weeks since the injection and I still have a severe headache. Blood pressure has also been elevated resulting in physician prescribing blood pressure medication.
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| 56 | 2021-01-25 | chest discomfort |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-25 | palpitations | s/p 1st dose vaccine c/o feeling flushed with palpitations and dizziness |
| 56 | 2021-01-26 | blood pressure increased | Elevated blood pressure, rectal bleeding,and dizzy. Last for about 48 hours |
| 56 | 2021-01-26 | chest pain |
Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spon...
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Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that she the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) at single dose for vaccination on 22Dec2020. Relevant medical history included Rheumatoid, Asthma, Artery disease, Gastroparesis. Relevant concomitant drugs were unknown. The patient had a headache with the first COVID-19 Vaccine and a little bit of chest pain. Stated she has heart troubles. Outcome of events was unknown.
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| 56 | 2021-01-26 | heart rate increased | c/o rapid pulse, observed, symptoms improved |
| 56 | 2021-01-27 | chest discomfort, pulse abnormal, fast heart rate |
15 minutes after vaccine given, complaints of chest pressure/tightness, tachycardia -pulse=120, c/o ...
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15 minutes after vaccine given, complaints of chest pressure/tightness, tachycardia -pulse=120, c/o forehead pressure. Team called, sent to ED
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| 56 | 2021-01-27 | palpitations |
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil...
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metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
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| 56 | 2021-01-28 | palpitations, blood pressure increased |
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ...
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close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-29 | body temperature decreased |
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa...
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Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
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| 56 | 2021-01-30 | chest pain |
Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling an...
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Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling and redness at injection site, swollen armpit, chest pain, extreme tiredness and slept for 22 hours, weakness.
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| 56 | 2021-01-31 | blood pressure increased, chest pain, fast heart rate |
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p...
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Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
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| 56 | 2021-01-31 | blood pressure increased |
Right after she received her dose, she just had a sore arm. 13 hours after vaccination, patient had ...
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Right after she received her dose, she just had a sore arm. 13 hours after vaccination, patient had a dry cough that woke her up from sleep. She then started to get a headache and took ibuprofen. She spike a temp of 99-102 degrees Fahrenheit. Blood pressure elevated to 165/100. One hour later it was 155/101. Normal baseline is 110-130/55. No visual changes occurred. After 8 hours, the blood pressure normalized. By 01/02/21, all symptoms had dissipated. I referred her to see her cardiologist for approval before second dose.
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| 56 | 2021-01-31 | transient ischaemic attack | after second dose feel like mild flu and body aches, light headache and little nusia |
| 56 | 2021-02-01 | hypertension, fast heart rate |
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa...
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Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
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| 56 | 2021-02-01 | hypertension |
General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in...
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General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
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| 56 | 2021-02-01 | heart rate irregular |
extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by ...
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extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
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| 56 | 2021-02-01 | heart rate increased |
short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a cont...
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short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686; expiration date: Mar2021), via an unspecified route of administration left upper arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included ongoing blood pressure high, ongoing hyperthyroidism reported as hyperthyroid, historically tachycardia from time to time resting, wears glasses, stressed and ongoing thyroid (thyroid disorder). Ongoing concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid and losartan for blood pressure high. She did not received other vaccination within 4 weeks. The patient stated that she first dose of the Covid vaccine and became short of breath and had a high heart rate afterwards after she got her vaccine. She mentioned that she had a high heart rate and shortness of breath on 31Dec2020 immediately after getting the vaccine. She received it at her workplace (in the hospital conference room) and was taken to the ER to be checked out. It was like soon as she sat down after getting the vaccine, she immediately started to have the high heart rate and shortness of breath. She wasn't sure if it was anxiety or a true adverse reaction. She further added that at first, she was thinking it was anxiety because she was stressed when first went there. However, she was reading the paperwork and it said high heart rate and shortness of breath could occur. After reading that she realized it may not be anxiety. When she was taken the Emergency Room and her heart rate then was 115-120 [units unspecified], she felt like it could have been higher before it was checked. She was kept in the Emergency Room for like 30 minutes or so for further observation. As a whole, the high heart rate and shortness of breath probably lasted no more than ten minutes. She confirmed she has recovered completely from the high heart rate and shortness of breath as she has not had any other episodes. She added, she gets tachycardia historically from time to time resting. However, she has never had shortness of breath and that is why she was concerned. She wants to know if she should get the second dose. The patient underwent lab tests and procedures which included EKG (electrocardiogram) and troponin were normal on 31Dec2020. The outcome of the events was recovered on 31Dec2020.
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| 56 | 2021-02-02 | chest discomfort |
About 10 minutes after receiving the vaccine, Patient began experiencing chest tightness, shortness ...
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About 10 minutes after receiving the vaccine, Patient began experiencing chest tightness, shortness of breath, and dizziness. 911 was called. 50 mg of Benadryl was given at 11:00, then 1 EpiPen administered at 11:10 when her symptoms worsened. Pulse ox was taken and was 97%. EMT arrived and the patient was transported to a local hospital. The patient reported feeling better when contacted by a site administrator later that day.
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| 56 | 2021-02-02 | chest pain | Sharp chest pain 30 minutes following administration of Moderna COVID-19 Vaccine DOSE 2 |
| 56 | 2021-02-02 | hypertension | Very enlarged lymph nodes in left axilla size of a grapefruit |
| 56 | 2021-02-02 | hypotension, fainting |
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho...
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syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-03 | excessive bleeding, transient ischaemic attack, cerebrovascular accident |
56 year old female presents with complaint of tingling and numbness that she noticed to her lower le...
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56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood
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| 56 | 2021-02-03 | palpitations | Heart palpitations/racing heart. Dr. Appointment scheduled. |
| 56 | 2021-02-03 | heart rate increased |
Heart rate at 210 for approx. 10-15 mins. I was driving when event occurred and I had to pull over ...
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Heart rate at 210 for approx. 10-15 mins. I was driving when event occurred and I had to pull over and wait until heart rate came down. I have Exercise induced but never had a SVT event without exercise like this.
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| 56 | 2021-02-04 | chest pain |
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site...
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chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-05 | chest discomfort |
Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating d...
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Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating down the ribs, extreme fatigue, body aches, dull headaches. 1/8- chest tightness, temp 99.8, body aches, fatigue, dull headache. Only able to dose with Tylenol. 1/12-follow up: states doing well and all symptoms subsided.
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| 56 | 2021-02-07 | fast heart rate |
Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous repo...
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Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.
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| 56 | 2021-02-07 | fainting |
This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my ...
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This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my body. After 12 hours i began to get chills and my skin was very achey. I took advil because when i was very sick with covid and too tylenol every 6 hours it didn't lower my temperature or take away any of my pain. two hours later, i had a stomach ache. While having a bowel movement i fainted onto the floor and ended up with a black eye. i do not pass out from having bowel moments otherwise. My cheekbone was sore to the touch for a week.
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| 56 | 2021-02-07 | heart rate increased |
Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short o...
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Within a few miniutes, became slightly dizzy. After a few more miniuts, I became very dizzy, short of breath, something was going on in the back of my throat, heart rate went way up and I felt like I was going to pass out. About 09:10, I received an epi pen in my left thigh. After the epi pen, my symtoms resolved very quickly. I was then sent to the ED for a 4 hour observation. While in the ED, I received a unit of fluids. After which, I was discharged home.
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| 56 | 2021-02-08 | fainting |
Pt states she had pain in deltoid, scapula, trap and interscalenes, states it started after the surg...
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Pt states she had pain in deltoid, scapula, trap and interscalenes, states it started after the surgery. Pt continues to have this pain 4 days out. Pt had two syncopial episodes at home, I spoke with her pcp and this is normal reaction for her to vaccines. Pt has had fever ranging from 101 to 104 for past 4 days since the second dose of her covid vaccine.
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| 56 | 2021-02-10 | hypotension, heart rate decreased |
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating,...
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While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out. Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low. Called 911. Put oxygen on me, gave me Epipen, and checked sugar levels. Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up. Gave me water and orange juice. Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers. I was still trying to feel back to myself after a half hour to 45 minutes. My doctor says not to get 2nd dose in which I'm due on 2/21/2021. I started to feel back to myself around an hour later. I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing. No fever. I called my physician on 2-1-2021 to let her know what happened.
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| 56 | 2021-02-11 | oxygen saturation decreased |
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1...
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Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
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| 56 | 2021-02-14 | chest pain |
After first dose severe headache for two days with some dizziness. After second dose sleepless that...
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After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
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| 56 | 2021-02-14 | haemoglobin decreased, platelet count decreased |
Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech)...
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Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21.
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| 56 | 2021-02-15 | fast heart rate, hypertension |
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt...
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1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
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| 56 | 2021-02-15 | chest discomfort |
I felt tightness in my chest and had green mucas deep down in my chest as if I had a flu or cold. I...
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I felt tightness in my chest and had green mucas deep down in my chest as if I had a flu or cold. I could not cough it up on my own. I used my nebulizer with albuterol to alleviate the tightness in the chest and help loosen and expel the mucas. If this had been allergy related the mucas would not have been so deep in the chest and difficult to expel.
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| 56 | 2021-02-21 | blood glucose increased |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-21 | nosebleed, hypertension |
Nosebleeds with elevated blood pressure began at 7:00 am on February 14, took 45 minutes to control ...
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Nosebleeds with elevated blood pressure began at 7:00 am on February 14, took 45 minutes to control at home, 2nd nosebleed February 15 at 5:00 am took 45 minutes to stop at home, saw PCP at 10:00 am, referred to ENT, February 16 nosebleed at 5:00 am, went to ER at 8:00 am, applied Afrin and TXA, February 17 Midnight nosebleed back in ER at 1:00 AM, silver nitrate used to cauterize 2 spots on right side of nose, February 17 10:00 PM nosebleed stopped after 45 minutes starting bleeding again at 1:00 AM went to ER recauterized one spot. February 18 appointment with ENT cauterized several areas with silver nitrate, February 21 10PM nosebleed again went to ER per ENT instructions, stopped bleeding, they put in afrin, got home Februray 22 1:00 AM bleeding started again applied afrin and pressure, stopped 30 minutes later. Appt with PCP February 22 at 10:00 am
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| 56 | 2021-02-21 | heart rate increased |
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal...
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Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
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| 56 | 2021-02-22 | chest discomfort |
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes...
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Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-23 | chest discomfort |
Patient complained of heaviness in chest and lightheaded. Patient remained in observation for and a...
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Patient complained of heaviness in chest and lightheaded. Patient remained in observation for and additional 30 minutes before leaving the site.
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| 56 | 2021-02-23 | palpitations |
Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports h...
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Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports her heart was racing and still feeling dizzy. EMS onsite and pulse was 90, BP of 170/88, patient was taken to hospital for further evaluation.
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| 56 | 2021-02-23 | loss of consciousness |
Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such...
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Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such as ?I?m going to die! This vaccine is going to kill me!? Immediately after receiving vaccine (less than 3 seconds) patient slumped down in chair, writer to the patient, patient stating ?I can?t breathe, its going dark, I?m going to die! What about my daughter!? Writer and vaccinator attempted to talk patient down, ineffective. Patient V/S 100/60, 66-HR, 98%-O2, 22-Resp. Patient became limp in chair, unresponsive, episode of urinary incontinence, EMS activated. ~90 seconds into episode patient regained consciousness, A&Ox4, stating ?I?m back. I?m back.? Patient reports this last happened to her ?in college?. Patient also states ?my doctor told me not to get the vaccine, to wait until August since I have Lyme Disease.? Patient to ED with EMS.
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| 56 | 2021-02-24 | chest pain | Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats |
| 56 | 2021-02-24 | chest discomfort, chest pain |
Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I wo...
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Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I would deep breath to calm down. Took my Pulse/O2 and it was 98% and 62BPM and BP was 107/58 that day (6 Feb). Took it the next day and we had a 98% and BPM of 58 and BP went to 148/72 ( very unusual for me). 4 days later took Pulse/O2 at 98% 58BPM and BP at 120/62. I feel pain in the center of my chest where my heart is and I have never had this in my life until 2 days after the vaccination. I am now taking a lung support (Clear Lungs - Nutritional Therapeutics) in case I have a lung issue. I live at 5000' and can walk and I now only do light exercise so I don't feel the heaviness or "stress" feeling in my heart. I have not gone to the dr yet. On 8 Feb my chest was really hurting and did feel some pain on my lower jaw and this went on for about 2 hrs. I did not go to the hospital. Something is wrong since getting this shot even though the symptoms are subsiding. Again, for someone without comorbidities or a history of her heart ever hurting to have this happen 1 1/2 days after the vaccine is not a coincidence and from all data that can be found this is an anomaly. I am troubled and concerned about my reaction.
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| 56 | 2021-02-25 | blood pressure increased, chest pain, blood glucose increased, chest discomfort |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She was sent to the ED from here for further evaluation of chest pain. She states her bp continued to be elevated but they gave her an anti-inflammatory shot for her chest pain. States it helped a little but not much. States last night was "rough" but got better through the night and "honestly I didn't feel better until noon today." Took her bp today and it was 148/98. She has not contacted her pcp for follow up. She was reminded to continue to track her bp and record. It was also recommended that she contact her pcp tomorrow to get in sometime next week to be further evaluated and f/up on bp. She is aware of when to return to ED for worsening or new symptoms discussed today. Pt voiced appreciation for the phone call/follow up. Denies any other questions or concerns. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Attempt to call patient for follow up via phone. No answer. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Date: 2/24/2021 Subjective Pt is a 56 y.o. female who was seen at clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness. She denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. PMH: DM and HTN. She was taken off Actos here in the last couple of weeks and switched over to Glipizide. She also takes 10 mg of Lisinopril at night time. She also takes Morphine BID for chronic pain. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness and dizziness Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0915 02/24/21 0928 02/24/21 0939 02/24/21 0945 BP: (!) 155/82 (!) 159/93 (!) 154/79 (!) 156/88 BP Location: Left arm Left arm Left arm Left arm Patient Position: Sitting Sitting Sitting Sitting Pulse: 87 SpO2: 99% Blood Sugar 185 collected at 0915 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: fair. Patient discharge: Transported to ED by POV. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) During her stay she was monitored. After zyrtec was administered and she was laying down. She reported to feel a little better. Upon ambulation to evaluate, she reported lightheaded and chest tightness worsening slightly. She states she has her husband out front who is "angry with me for even being here." We discussed reasons for further evaluation as I am limited here. She declines Ambulance and states her husband won't take her but she would take herself or find a friend. Pt stable. Taken out in wheelchair. Pt ambulates without assistance. 2/24/2021 11:11 AM
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| 56 | 2021-02-25 | nosebleed |
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As...
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Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
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| 56 | 2021-02-26 | low blood oxigenation |
Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on anti...
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Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on antibiotics and steroids empirically prior to admission 02/15. Initial CT with diffuse centri-lobular tree and bud opacities. Infectious (including BAL) and autoimmune work-up without clear explanation for infiltrate. Underwent VATS wedge resection for tissue diagonsis. Post-op developed hypoxia requiring up to 10L O2 and worsening infiltrates on CT in a pattern consistent with organizing pneumonia (possibly drug reaction). Started empirically on steroids for concern for organizing PNA/hypersensitivity pneumonitis. Pathology returned with organizing pneumonia with increased eosinophils. Timing of onset of symptoms is concerning for a hypersensitivity reaction to the COVID vaccine. Symptoms are improving with steroids (started 02/26). Recovery to be determined but I am optimistic for a good recovery.
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| 56 | 2021-02-27 | palpitations | Dyspnea, heart palpitations, cleared by EMS |
| 56 | 2021-02-28 | chest pain | Achy no fever chills couldn't breathe anxiety chest hurts. |
| 56 | 2021-02-28 | palpitations |
Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is...
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Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.
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| 56 | 2021-02-28 | blood pressure decreased, loss of consciousness, heart rate decreased |
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ...
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almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
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| 56 | 2021-02-28 | palpitations |
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo...
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legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
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| 56 | 2021-03-02 | fast heart rate, heart rate increased, chest discomfort |
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s...
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12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
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| 56 | 2021-03-02 | excessive bleeding |
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane...
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Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
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| 56 | 2021-03-02 | blood pressure increased |
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL...
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VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
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| 56 | 2021-03-02 | chest pain |
Within 24 hours patient reported SOB and chest pain. Medication Error: patient was given Pfizer a...
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Within 24 hours patient reported SOB and chest pain. Medication Error: patient was given Pfizer as a booster on 2/28/2021 yet Moderna was her 1st Vaccine on 1/31/2021. No reactions day of vaccines.
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| 56 | 2021-03-03 | fainting, blood pressure decreased |
Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nau...
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Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nausea, fainted at 6 pm on 02/27/21,, no response or movement. Blood pressure dipped down to 60/42 ...Ambulance came. EMT measured the blood pressure... 60/42 Was taking Tylenol 2 tablets of 500 mg. (max out) Fever will go down for an hour but would be back with extreme chills. Symptoms Fever, chills, body aches persisted for 30+ hours.
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| 56 | 2021-03-03 | arrhythmia |
Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea);...
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Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea); chills; fever to 100.8; muscle, bone and joint aches; severe fatigue; weakness; slight headache, no appetite. Alleviated somewhat with naproxyn sodium and benadryl. I also felt like I had cardiac arrhythmias. Slept most of day on 2/27. Felt improved morning of 2/28 and back to "normal" Monday 3/1.
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| 56 | 2021-03-03 | heart rate irregular, chest discomfort, chest pain |
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Within 10 minutes of receiv...
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Within 10 minutes of receiving vaccine, patient reported chest pain feeling like a pinching/stabbing. We had trained EMTs along with pharmacists. Reported 5/10 pain. Patient has hx of high blood pressure, high cholesterol, arthritis, and angina. Heart rate taken and it was irregulaerly irregular but after given a dose of aspirin 324mg it was back in normal sinus rhythym. Gave IV NaCl and taken by rescue. on departure was symptom free. no SOB, hives or chest pain.
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| 56 | 2021-03-04 | blood clot | Blood clot on thigh |
| 56 | 2021-03-04 | chest pain |
Pt had second dose of Pfizer vaccine at 09:20. Stated she had headache on left side and left-sided c...
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Pt had second dose of Pfizer vaccine at 09:20. Stated she had headache on left side and left-sided chest pain at 09:25. Not associated with other symptoms. Vitals taken BP=165/101 Resp=24 O2=100%RA,. Reported to EMS. Established IV, 4 81mg aspirin given. Pt placed on telemetry monitor. Pt states CP resolved prior to transport to hospital.
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| 56 | 2021-03-05 | nosebleed |
Noticed blood in nostrils at about midnight Woke up with bad headache Woke up with blood in nostrils...
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Noticed blood in nostrils at about midnight Woke up with bad headache Woke up with blood in nostrils. Now 11:45 a. m. and still blood on tissue.
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| 56 | 2021-03-09 | chest discomfort, fibrin d dimer increased, heart rate increased |
Fatigue, fever x 2 days. Then started with constant chest pressure, elevated heart rate which is co...
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Fatigue, fever x 2 days. Then started with constant chest pressure, elevated heart rate which is continuing since first vaccine.
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| 56 | 2021-03-09 | chest pain |
Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure an...
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Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure and left upper arm pain that is still on as I am reporting this side effect today.
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| 56 | 2021-03-09 | palpitations |
begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bil...
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begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bilateral body sides from cheeks to ankles, became dizzy though I would pass out, begin shaking then had some nausea, heart was racing. It felt like the tingling was surging through my body. made it to couch to lie down took 12.5 mg Benadrly ODT. some relief then after about 5 min begin again 911 called ambulance to Hospital
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| 56 | 2021-03-10 | chest discomfort |
03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face s...
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03/04/2021- Difficulty breathing and chest tightness, off and on throughout day. 03/05/2021- Face swelling on the left side and also swollen lymph nodes, symptoms still continue 03/11/2021.
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| 56 | 2021-03-12 | heart rate increased, blood pressure increased |
About 5-7? after vaccine, had high heart rate (155 on her smart watch). Also had intermittent dizzin...
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About 5-7? after vaccine, had high heart rate (155 on her smart watch). Also had intermittent dizziness. Brought over to a cot, took vitals once on cot 2 minutes. Bp130/82 (pt reports that is a little high for her), pulse 96, RR 14/min. Recovered within 35 minutes, asked to leave because she felt better. Called pt. @ 12:15pm and she stated, ?I feel totally fine, my heart rate is 80 or less like normal and not at all dizzy.?
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| 56 | 2021-03-12 | blood pressure increased |
At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/...
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At my OMT (Oestopathic Manipulative Therapy) Dr. appt on Wednesday, 3/10/21, my BP was 134/80. On 3/12/21, Friday afternoon around 2:30pm, I noticed my left eye didn't feel right. I looked in the mirror and my left eye was slightly red in the corner of my eye towards my nose. When I woke up this morning on 3/13/21, my eye was completely red in that same corner of my left eye. I went to the a walk-in clinic this morning to have it checked out. The doctor indicated that it was a burst blood vessel in my eye and that the redness should go away in about a week. My BP was 148/100. The doctor asked if I had a history of high blood pressure and I told him no and showed him 3 of my previous BP card records that I keep in my purse. He said I should monitor my blood pressure and follow up with my primary care doctor. I have had a blood vessel burst in my eye before a few years back. I do not remember which eye. I have had fibromyalgia for over 20 years. I was diagnosed with Occular Myesthenia Gravis in January 2017 which affects my left eye only.
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| 56 | 2021-03-12 | chest pain |
Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild ches...
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Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild chest pains 10 min post injection
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| 56 | 2021-03-13 | chest discomfort |
Patient felt anxious and said she was experiencing tightness and pressure in her upper chest. Denied...
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Patient felt anxious and said she was experiencing tightness and pressure in her upper chest. Denied any difficulty breathing and did not seem to be in any immediate distress. No swelling or difficulty breathing was obsereved. Patient sat in observation area for at least 30 minutes and was given a small bottle of water. Vitals were taken after that time. Heart rate was 87 bpm, blood pressure was taken on a machine and results were 187/90. Oxygen saturation was 97%. Patient was given option to be taken over to ER to be evaluated and she said "yes". Told later by ER doctor that patient claimed syptoms had resolved and left AMA before any other diagnostic tests were preformed.
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| 56 | 2021-03-14 | hypertension, chest discomfort, blood pressure fluctuation |
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre...
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annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
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| 56 | 2021-03-15 | chest pain |
3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BR...
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3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BREATHE IN'. 3-15-21 11:20AM PT STATES 'FEELS BETTER NOW'. ADVISED TO CALL HEART DR R/T DOSE#2.
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| 56 | 2021-03-15 | fainting | Dizziness, fainting, muscle pain, fatigue, headache |
| 56 | 2021-03-15 | palpitations |
Received Pfizer vaccine @ 10:00 am in my left arm. Heart palpitations and headache started about 2 ...
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Received Pfizer vaccine @ 10:00 am in my left arm. Heart palpitations and headache started about 2 hours after vaccine. Took Tylenol around 3:00 pm because headache worsened. Around 7:00 pm, I broke out in a red bumpy and very itchy rash around both ankles, with the worst being on my left ankle. I took Benadryl and rubbed Cortizone 10 on the rash. Rash did not spread any further overnight, but heart racing continued throughout the night. By 03/12/2021, I was no longer itching, but still had the rash. Heart palpitations/racing was gone.
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| 56 | 2021-03-16 | chest pain, chest discomfort |
Patient received vaccination at approximately 10:39. At 11:05, patient c/o headache and chest tightn...
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Patient received vaccination at approximately 10:39. At 11:05, patient c/o headache and chest tightness. Had visible heart monitor in place. States had chest pain x one week and just increased blood pressure and diabetic medications. Provided juice. Vital signs stable throughout the episode. Monitored for approximately 30 minutes and left on own accord.
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| 56 | 2021-03-16 | cardiac arrhythmia, chest discomfort |
Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minut...
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Patient with numbness of lips, chest heaviness and lightheadedness with onset approximately 25 minutes after administration of vaccine. Normal SpO2 97%. BP initially slightly elevated 147/87, repeat 126/72. RR 20, HR 91. No wheeze, stridor or difficulty breathing. Dry mouth reported, no swallowing difficulty. Patient calm, no diaphoresis or pallor. Skin warm and dry. EKG (3 lead) with normal sinus rhythm, occasional premature ventricular contractions, no significant ST/T wave changes. Symptoms of chest pressure resolved spontaneously within 30-45 minutes with monitoring, no treatment required. Lip numbness significantly improved, minimal upper lip sensation changes persisted . No swelling of lips or tongue or throat. Patient never experienced tachypnea, tachycardia or diaphoresis. Patient declined ER transport via EMS. Precautions discussed - if persisting or recurring symptoms, encouraged patient to call 911 or contact PCP.
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| 56 | 2021-03-16 | fainting | Vasovagal syncope |
| 56 | 2021-03-17 | chest pain, palpitations |
Severe palpatations and chest pain. Medication was preventing any palpatations until vaccination. He...
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Severe palpatations and chest pain. Medication was preventing any palpatations until vaccination. Heart began to work really hard every beat. Tired and fatigued
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| 56 | 2021-03-17 | chest pain, blood clot | blood clot leading to brain stem stroke, intubation, shortness of breath and chest pain |
| 56 | 2021-03-18 | loss of consciousness |
Fever, chills, headache, N/V, injection site pain beginning 3/13/2021, reports that she "passed out"...
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Fever, chills, headache, N/V, injection site pain beginning 3/13/2021, reports that she "passed out" on 3/13/2021. Spoke with PCP who advised her to go to hospital but she did not go. Taking tylenol as needed. Started feeling better yesterday, eating and drinking. Advised to follow PCP recs and we will follow up with her tomorrow.
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| 56 | 2021-03-18 | ischemic chest pain | Heart Pain and difficult breathing |
| 56 | 2021-03-18 | heart rate irregular |
LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable 56-year...
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LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable 56-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscula, administered in Arm Right on 07Jan2021 (Batch/Lot Number: EJ 1686) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient experienced loss of bladder control and irregular heartbeat on Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included heart rate: irregular on 2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
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| 56 | 2021-03-18 | heart rate irregular |
LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other h...
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LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot # EL9261), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced loss of bladder control, irregular heartbeat. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
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| 56 | 2021-03-19 | palpitations |
5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. ...
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5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. For the remainder of the day into the evening I had heart palpitations. The following day I felt tired and nauseous until around 11am. My arm is sore and itchy.
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| 56 | 2021-03-20 | chest pain |
I had my first shot around 10 am and my left arm was very sore and got progressively worse. I playe...
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I had my first shot around 10 am and my left arm was very sore and got progressively worse. I played golf the next day (Tuesday) and I woke up in the middle of the night with nagging shoulder and chest pain. I was concerned it was heart related. It continued for 2 weeks off and on but fairly intense at times. Not sure if I slept on it funny. When to my primary care dr and had an X-ray and ekg. Both came back negative. I am still having chest pain so I am calling again 3/22 to discuss with dr.
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| 56 | 2021-03-21 | hypotension, heart rate decreased, fainting |
Patient received her 1st dose of Covid-19 Pfizer vaccine, lot #ER2613, today at 1:19pm at the Vaccin...
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Patient received her 1st dose of Covid-19 Pfizer vaccine, lot #ER2613, today at 1:19pm at the Vaccination clinic. While waiting in the parking lot, patient got medic's attention and was not feeling well. Patient reported to have a syncopal episode around 1:30pm with low blood pressure and low heart rate. Medics started IV with IV fluids, which stabilized patient's vital signs. Patient was transported to the hospital.
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| 56 | 2021-03-21 | loss of consciousness, fainting |
syncopal episode after injection. Patient unconscious for approximately 5 minutes, transferred fro...
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syncopal episode after injection. Patient unconscious for approximately 5 minutes, transferred from chair to gurney to EMT triage area. 5:20 pm - BP 129/78, p-64, O2 sat- 94%, given water, and monitored. Denies chest pain, Shortness of breath, dyspnea , no dizziness. Sitting- 5:30 pm - BP 128/76, p-69, O2 sat- 94% Able to stand without difficulty. 5:35 pm - patient discharged with husband, able to stand without difficulty. When she returns for second dose, she will let the staff know and she will receive her vaccine in the triage room while lying down on gurney.
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| 56 | 2021-03-22 | palpitations |
About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started...
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About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started racing, my hands started shaking, and I felt dizzy and lightheaded and my hands also felt numb. The worst of it probaby only lasted 5 minutes. I felt well enough to drive home but was still lighthead and shaky for about 45 minutes. An hour later, I feel ok except for a little lightheadedness.
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| 56 | 2021-03-22 | heart rate abnormal |
Pt reported shortness of breath and fast heart rate. Pt received vaccine at approx. 1410, about 2 m...
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Pt reported shortness of breath and fast heart rate. Pt received vaccine at approx. 1410, about 2 minutes later pt reported SOB and fast heart rate. Pt then took 2 puffs of albuterol inhaler and reported it was not helping. Pt reported faster heart rate and difficulty breathing. Pt was given 1 dose of auto-injector epi 0.3 in left thigh. Pt was taken and guided to ground from car seat with assistance and place on shaded concrete. EMS was notified and en route. Pt was monitored with CNO at bedside. Pt was tachy 118 with 96% pulse ox on RA. Maintained own airway which was patent without obstruction.
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| 56 | 2021-03-23 | palpitations |
Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my ey...
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Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my eyes are little bit weaker; seems like my eyes are little bit weaker; Heart feels like racing; This 56- year-old female consumer (patient) reported for herself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6201 ), via an unspecified route of administration, on 20Feb2021 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "I had my second shot of Pfizer vaccine yesterday (20 Feb 2021), today, I suffered being tired. I put on my glasses to watch movie and screen looks fuzzy. It seems like my eyes are little bit weaker or something. My heart feels like racing. I don't think it is racing but it feels like it is. I was wondering if there is any side effects like slightly less accurate vision." The outcome of the events looks tired, fuzzy, eyes weaker, and heart feels racing was unknown.
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| 56 | 2021-03-23 | lightheadedness, chest discomfort |
about a minute after injection, started shaking, sweating, got very light headed with the feeling I ...
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about a minute after injection, started shaking, sweating, got very light headed with the feeling I might pass out. Chest got very tight and breathing was strained. Waited with a pharmacy tech, drank water, called husband to come pick me up. Blood pressure went to 178/110, heart rate up to 154 before it subsided. Was able to leave after 45 minutes. Took Benadryl for the next 48 hours to stop reaction. Had waves of the same symptoms several times a day for 4 days after injection.
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| 56 | 2021-03-24 | loss of consciousness |
03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she wok...
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03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she woke she was c/o upset stomach and vomited twice. Was brought to hospital and stayed for 3 h0ours. Headache is still
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| 56 | 2021-03-24 | chest discomfort, chest pain |
Chest pain - about 30 minutes after inoculation, pt began experiencing chest tightness; resolved in ...
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Chest pain - about 30 minutes after inoculation, pt began experiencing chest tightness; resolved in ED without medical intervention.
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| 56 | 2021-03-24 | chest discomfort, fast heart rate |
Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensatio...
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Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensation, chest tightness, pain radiating into left arm and left leg. Tx: diphenhydramine 50 mg orally every 10 min until symptoms lessened/resolved. Aprox 300 mg over 30 min All symptoms resolved within 60 min
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| 56 | 2021-03-24 | blood pressure decreased |
dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a litt...
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dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a little bit of something in her bladder, in her urine; she had a little bit of something in her bladder, in her urine; woke up completely drenched; Blood pressure dropped; Vomiting; nauseated and couldn't eat; nauseated and couldn't eat; high fever/ It got to over 103; Diarrhea is like a greenish color; diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 56-years-old, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included kidney and pancreas transplant patient since 01Apr2014 (On 01Apr2021, will be seven years since her transplant), Gastroparesis from 2005, Small intestinal bacterial overgrowth from 2019 (hasn't had any issues with that in over a year), Diabetic macular edema (Doesn't think Diabetic macular edema pertains to anything with the COVID Vaccine), pacemaker in her stomach (Procedure for pacemaker for stomach performed first time in 2006. Stomach pacemakers only last eight to ten years. Had the battery replaced in 2017), she had previously had C-Diff, high blood pressure (Doesn't have high blood pressure anymore), immunosuppressed. The patient's concomitant medications were not reported. Patient states about a week ago, she talked to someone at clinic, reporting after she got the first dose of the Pfizer COVID 19 vaccine. She had reported she had diarrhea. Clarifies she got her vaccine on 03Mar2021 at 15:00PM in the right arm. She previously reported she started having diarrhea in the night, Thursday (04Mar2021), and had it for ten days. At that time, when she had reported, she only had diarrhea. Diarrhea is like a greenish color. Has been trying not to eat heavy things, but diarrhea is still a greenish color. She contacted her stomach doctor and he wanted her to do a COVID 19 test, which was negative; and a whole stool work up because she had previously had C-Diff. She did all that and turned it in Friday. Adds she did have the chills a little on the day of the vaccine but they went away. Reporting new events today including on 13Mar2021 she started having a fever. It got to over 103; she was so nauseated she couldn't eat (13Mar2021); with chills (03Mar2021) and shaking (unspecified date). She treated the fever with Tylenol and got some relief but then her fever would go back up. She thinks she was getting dehydrated (Mar2021) from all the diarrhea and then she started to throw up on Tuesday (16Mar2021). That day she was admitted to the hospital, 16Mar2021. At the hospital they did another COVID 19 test that was negative; blood tests; urine test; US kidney; CAT Scan whole stomach; and they could not find anything that could cause her symptoms. Adds they did say she had a little bit of something in her bladder, in her urine (unspecified date). While hospitalized she was treated with IV antibiotics; Phenergan and Zofran which controlled the nausea and vomiting. Her fever went down to 99 by Friday. Adds she did have one episode on Friday of low blood pressure (19Mar2021) and they were watching it. She was discharged on Saturday and has not had a fever since she came home. Adds she did have a bowel movement that was loose but not like it was, not diarrhea (unspecified date). Mentions for the last two nights she woke up completely drenched (20Mar2021) but she did not have a fever. Adds she felt a little chill last night, but she just covered up with her blanket. She feels her dehydration is improving. Therapeutic measures were taken as a result of dehydrated, high fever/ it got to over 103 (pyrexia), vomiting, nauseated and couldn't eat. The outcome of dehydrated was recovering, diarrhea and diarrhea is like a greenish color was recovered on 18Mar2021, high fever/ it got to over 103 was recovered on 19Mar2021, chills was not recovered, vomiting recovered on 17Mar2021, nauseated and couldn't eat recovered on 18Mar2021, blood pressure dropped recovered on 19Mar2021, woke up completely drenched was not recovered, and all other events was unknown. The patient was hospitalized for dehydrated from 16Mar2021 to 20Mar2021.
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| 56 | 2021-03-25 | chest pain, chest discomfort |
Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore...
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Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore throat
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| 56 | 2021-03-25 | cardiac arrhythmia, blood clot, hypertension |
I noticed increasing episodes of SOB, dizziness, and PVCs. My blood pressure continued to increase....
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I noticed increasing episodes of SOB, dizziness, and PVCs. My blood pressure continued to increase. After 4 weeks of increasing symptoms I reported to the ED. I was admitted for Right Lower Lobe blood clot, hypertension, and PVCs.
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| 56 | 2021-03-25 | heart rate increased |
Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (s...
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Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (she has COPD and has not used her rescue inhaler) and a rapid heart rate.
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| 56 | 2021-03-25 | chest discomfort |
VR reported chest tightness and coughing. EMS was called to site. VR rec. epi, albuterol, and benedr...
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VR reported chest tightness and coughing. EMS was called to site. VR rec. epi, albuterol, and benedryl in the ambulance and was transported.
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| 56 | 2021-03-26 | palpitations, chest discomfort |
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch...
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March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
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| 56 | 2021-03-27 | chest pain |
Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swe...
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Sarcoidosis was in remission. I am now in full blown flare with severe joint pain and stiffness, swelling, redness. Extremity swelling. Coughing and chest pain. Extreme fatigue. Today, the pain is so bad I am on the couch. Doctors visit tomorrow
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| 56 | 2021-03-27 | loss of consciousness |
blacked out or fell asleep while driving to work the next morning which resulted in a car accident; ...
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blacked out or fell asleep while driving to work the next morning which resulted in a car accident; no recall of driving; extreme confusion during the day. Heaviness in head for several days; fatigue for several days
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| 56 | 2021-03-29 | hypertension, chest discomfort |
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac...
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The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
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| 56 | 2021-03-30 | hypotension |
Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minim...
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Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi. Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well. While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved. She had a significant period of hypotension for appx. 20 minutes however (prior to improvement). Unclear if she had a prolonged vasovagal response or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis. She was transported to local ER by EMS in improved condition.
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| 56 | 2021-03-31 | heart flutter, palpitations |
she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was ti...
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she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was tired and sleepy; she was tired and sleepy; right thigh area in the muscle feels throbbing and pain; Fluttering Heart Beat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 18Mar2021 at 08:15 (batch/lot number: ER2613) as a single dose for COVID-19 immunisation (also reported as "preventing COVID-19 virus"). Medical history included ongoing rheumatoid arthritis diagnosed 15 years ago, type 2 diabetes from Jun2019 and ongoing, and ongoing high blood pressure diagnosed about 25 years ago. Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2020 (started it a year ago) and ongoing; insulin detemir (LEVEMIR) taken for type 2 diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for type 2 diabetes from 2019 and ongoing. The patient previously took tofacitinib citrate (XELJANZ) prior to adalimumab. The patient stated that she has a question. She received her first dose today at the in (City name). Stated they gave out a fact sheet upon leaving after vaccine. She stated the sheet stated that she should mention if she was immunocompromised or on medication that compromises the immune system. Asked should she be expecting something different. Stated no one asked her or told her before she got the vaccine. On 18Mar2021, she stated that she felt a fluttering heart beat that lasted for a half hour. She stated that she got the vaccine at 08:15, and about a half hour after (08:45) that she had a racing heart. She stated that she felt like she was clunked over the head, she was tired and sleepy but that has passed. She stated that her brother mentioned he had this too after his vaccine but resolved. Stated her right thigh area in the muscle feels throbbing and pain, nothing excruciating. Stated it was nothing to notice, her brother said he felt the same thing after his vaccination 2 days ago. For the event fluttering heart beat, stated that she had to sit down because she didn't know what was happening but it went away. For the event right thigh area in muscle throbbing and pain, stated it could be muscle of thigh, pain throbbing, not injection site. For the event tired and sleepy, stated that when she got home she first wanted to lay down and take a nap but thought she needed to stay awake. Stated sometimes she wakes herself up with anxiety or maybe it was side effects but she felt like she was starting to come around. She stated that she only has 10 minutes before she needed to walk out the door for an appointment. She still wanted to speak with Medical Information so she wanted to be transferred since she doesn't have much time before she needs to go. The outcome was recovered on 18Mar2021 for the events "fluttering heart beat" and "heart racing", and recovering for the rest of the events.; Sender's Comments: Linked Report(s) : PFIZER INC-2021307886 same reporter/drug/events, different patient
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| 56 | 2021-04-02 | blood pressure increased |
her throat itches; she could not breath; her pressure raised to 230; throat started to close; This i...
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her throat itches; she could not breath; her pressure raised to 230; throat started to close; This is a spontaneous report from a contactable consumer (patient's husband). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 56-year-old, via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband commented that both of them got the first dose of the Pfizer covid vaccine on 07Mar2021 and some minutes later, the patient started having a reaction that she had to be taken into the ER with an ambulance: her throat started to close, she could not breath and her pressure raised to 230. Until today, she has not fully recovered, and they have been getting in and out of the ER, in fact they just arrived home from there. Physicians only prescribed antiallergy medications and the patient was still having the same problem and her throat itches on an unspecified date. The physicians they have consulted have contradictive opinions about how she should do: one recommended her not to get the second dose while another recommended her to get started again on the series. The husband wants to know what they can do about this. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 56 | 2021-04-08 | chest pain |
57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication ...
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57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication completed her 15 minute observation period post administration of her 2nd Pfizer COVID vaccination. As she walked out and she began listing to the right side. She sat down, confused, and complaining of chest pain. She also noted pruritus over her face and scalp. No c/o Shortness of Breath, wheezing or nausea. She was immediately evaluated by me and EMT's . Vital signs demonstrated a HR of 74 in sinus rhythm, O2 Sat of 98% and BP was 192/104. She did not have a rash but was scratching at pruritic areas on scalp and face. See continuation page...
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| 56 | 2021-04-10 | blood glucose increased, fast heart rate, heart rate increased, chest pain, blood pressure increased |
sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe...
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sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50. By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe. Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events. Follow up needed, further information has been requested.
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| 56 | 2021-04-12 | heart rate increased, nosebleed |
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s...
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elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
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| 56 | 2021-04-15 | platelet count decreased |
03/06//2021: Seen in ER for severe headache. BP checked and was good. Covid test = Neg. Labs draw...
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03/06//2021: Seen in ER for severe headache. BP checked and was good. Covid test = Neg. Labs drawn and shows low plt count. MRI showed lesions/clots on brain. test for Lupus = Neg. Hep panel = Neg. Admitted to hospital for 17 days. Treatment with plasmapheresis, rituximab and steroids.
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| 56 | 2021-04-15 | pulmonary embolism, palpitations |
Pt had her second COVID vaccine on March 27th 2021, On April 4th 2021, the patient went to the ER ...
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Pt had her second COVID vaccine on March 27th 2021, On April 4th 2021, the patient went to the ER due to shortness of breath, dizziness, and racing heart rate. After patient participated in physical activity she had to lay down afterwards due to the shortness of breath. Pt spent 2 days in the hospital after being diagnosed with bilateral pulmonary embolisms. Pt was started on Xarelto and was discharged from the hospital on April 6th.
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| 56 | 2021-04-17 | cerebral haemorrhage, cerebrovascular accident |
bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's w...
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bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's walking, but her right leg is hard to lift up; still in a lot of pain; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:30 (at 56-year-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Vaccination Facility Type: Hospital. Concomitant medication included lisinopril (LISINOPRIL) taken for high blood pressure from an unspecified start date and ongoing. Caller states he is calling for his fiance, she's in the hospital. Caller states she had this vaccine done on the 22MAR2021 and had some side effects. Caller states she had a stroke (27Mar2021, hospitalized) and when he went online, he googled it about the shots, it actually said that COVID, the medicine, can cause the stroke, he actually watched a video about it. Caller states patient did good for two days then after two days, she woke up and couldn't remember hardly anything (25Mar2021, hospitalized) and he was questioning her like what month it was. Caller states he thought patient was playing with him, he waited a day and then her smile was stuck (25Mar2021, hospitalized) and when he got to the hospital, the doctor told him what happened. Caller states they actually want to keep her in a facility for therapy or rehab but she doesn't want to stay in the hospital and so they are seeing about getting therapy to come to the house. Caller states he works as a security officer. Prescribing Healthcare Professional: Caller states the healthcare she has is (state). Caller states he set up an appointment for her that she will be going. Caller states the patient hasn't gone there yet, she will be a new patient, on the 06 or 07. Caller states they are still at the hospital right now and all the information is at home. That doctor will be her new family physician. Caller states patient had the vaccine 22Mar2021 and she did good. Caller states then the next days she was not herself. He later clarified it was 25Mar2021 where she couldn't hardly remember anything, she was talking real funny. Caller states he's been around someone with strokes and he just wasn't sure so he told her he was going to take her to the hospital if she didn't get no better. Caller states she didn't get any better so she had bleeding on the brain (27Mar2021, hospitalized) and a stoke. Caller states the doctors told us what was going on and she was fine until she got the shot. Caller states it was about three days out from the shot. Caller states he would say she's not improving. Caller states the speech therapist came in, and wanted her to have therapy, they are really wanting to admit her. Caller states they told her she would have to get better. Caller states they talked to them about 40 minutes ago and he told them she didn't want to agree to that and they were trying to set it up where someone can come to the house for speech therapy and for her walking, she's walking but her right leg is still hard to lift up and just her memory, she doesn't remember her age. Caller states they said it could be up to six months before it gets better and if it don't, it's not gonna get better. Caller states on 27Mar2021, that's when they went to the ER and they did the CAT scan, that is when found out had a stroke and bleeding on the brain. Caller states he doesn't have the card she was given when she was received the shot, caller states that's at home. Outcome of stroke, bleeding on the brain, cannot remember anything : Caller states she has improved a little but everything is really about the same. Caller states she is still in a lot of pain and her memory's just not the same. Caller states they come in and they do tests on her, a word test, spelling test, she gets it right, she just has problems remembering her what her age is, what the month is, and what year it is. Caller states patient is supposed to get the second shot next week sometime, caller is unsure of the exact date. He mentioned he sees second dose it is within 2-3 weeks. No additional details provided. Caller states she was tested, they tested her there at the hospital, she just decided she wanted to get it. Caller states she didn't have the COVID any time. Caller states she had a CAT scan that showed bleeding on the brain and a stroke. Caller also reports she had a X-ray of the Chest, not sure of the results from that. Caller also states she had blood work done but doesn't know what it was or the results. Caller states he has to catch one of those doctors when they came in, but there was a lot of callers before him and they missed them. Time of Onset (24-hour clock) of Adverse Event was in the morning. Caller states they always get up, gets coffee started, 3-11 he does security. Caller states it was that morning, say around, she got up about 9:15AM (unspecified). It was also reported that she had Emergency Room visit. The outcome of the events she had a stroke, couldn't hardly remember anything, and bleeding on the brain was recovering; while for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 56 | 2021-04-17 | very slow heart rate |
brachycardia; Fatigue; rush through back of head that turned into headache; dizzy/lightheaded/feelin...
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brachycardia; Fatigue; rush through back of head that turned into headache; dizzy/lightheaded/feeling faint; This is a spontaneous report from a contactable consumer (reported for herself). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection), via an unspecified route of administration on 02Apr2021 12:15 (Batch/Lot Number: EP7533) as SINGLE DOSE, for covid-19 immunisation. Medical history included Asthma, factor v Leiden, heart pfo/ stroke 2003 surgically closed 2004 and known allergies was due to Penicillin. Concomitant medications included mometasone furoate (ASMANEX HFA); azelastine; triamcinolone acetonide (NASACORT); acetylsalicylic acid (ECOTRIN); calcium citrate, colecalciferol (CALCIUM CITRATE + D3) all were taken for an unspecified indication. The patient previously took Bactrim and, nystatin suspension and experienced allergies. It was reported that on 02Apr2021 12:15, within minutes of the injection patient got a it rush through back of head that turned into headache that lasted 5 days, immediately got dizzy and lightheaded, which lasted 3 days and ended up in ER (Emergency room) with brachycardia and feeling faint fit 2 days. Fatigue still ongoing, day 6. Patient was hospitalized from an unknown date in APR2021 for 2 days. Patient received treatment for AE as IV fluids, heart monitoring. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Apr2021. Outcome of the events was recovering.
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| 56 | 2021-04-20 | cardiac arrhythmia |
8 days after the 2nd dose, I started to experience heart PVCs on a frequent basis (approximately 4 p...
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8 days after the 2nd dose, I started to experience heart PVCs on a frequent basis (approximately 4 per minute)
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| 56 | 2021-04-20 | loss of consciousness, hypertension |
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L...
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Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
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| 56 | 2021-04-20 | heart rate irregular, palpitations |
I have had heart palpitations and what feels like an irregular heartbeat. It began , I believe a da...
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I have had heart palpitations and what feels like an irregular heartbeat. It began , I believe a day or so after receiving the 1st Pfizer vaccine although I can?t recall with absolute certainty if it started just before or shortly after being vaccinated.
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| 56 | 2021-04-21 | hypertension |
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. ...
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55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
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| 56 | 2021-04-26 | inflammation of the pericardium |
Pericarditis; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old ...
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Pericarditis; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), administered on the left arm on 03Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 05Mar2021, the patient had pericarditis; assessed as serious (medically significant). The event had resulted into an emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The patient had received bisoprolol as treatment for pericarditis. The patient had a negative nasal swab COVID-19 test on 10Mar2021. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 post-vaccination. The event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 56 | 2021-04-27 | chest discomfort |
Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). T...
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Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021330573 same patient, vaccine different dose
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| 56 | 2021-04-28 | very slow heart rate, palpitations, blood pressure increased |
heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light h...
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heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm. The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered. No follow up attempts are possible. No further information expected.
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| 56 | 2021-04-28 | excessive bleeding |
it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and ba...
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it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and back side were very pain full; sour belches; vomited; having dark liquid diarrhea pouring out of my rectum; I could not sleep; my entire stomach area was swollen and in extreme pain just to touch; my entire stomach area was swollen and in extreme pain just to touch; my back side was raw and bleeding; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 08Apr2021 18:45 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure (BP), sleeping, cholesterol. Patient had no covid prior vaccination. Concomitant medications included calcium and unspecified Multi Vitamin. No other vaccine in four weeks. The patient previously took erythromycin (EMYCIN) and experienced allergies, hydrocodone bitartrate/paracetamol (VICODIN) and experienced allergies. The patient experienced her back side was raw and bleeding on 12Apr2021, sour belches on 12Apr2021 08:00, vomited on 12Apr2021 08:00, having dark liquid diarrhea pouring out of her rectum on 12Apr2021 08:00, could not sleep on 12Apr2021, her entire stomach area was swollen and in extreme pain just to touch on 12Apr2021, her stomach and back side were very pain full on 13Apr2021, it was not liquid coming out of her rectum but a grey/taupe very soft stool on 14Apr2021, gassy on 14Apr2021. No treatment received. No covid tested post vaccination. Clinical course: She received the first Pfizer vaccine on 08Apr2021 evening, she thought it was easy, no problems. 12Apr2021 morning driving to work she started having sour belches, she got to work and ran to the bathroom, she vomited #6 times while having dark liquid diarrhea pouring out of her rectum, it finally stopped, 3 hours later it started again, she vomited 4 more times with more dark liquid pouring out of her rectum. Her boss sent me home. At home she was running back and forth to the bathroom the rest of the day with dark liquid diarrhea and another vomiting session throwing up #5 more times for a total of #15 Times. She could not sleep as her entire stomach area was swollen and in extreme pain just to touch and her back side was raw and bleeding. 13Apr2021 morning she vomited 3 times along with still having dark liquid diarrhea pouring out of her rectum and her stomach and back side were very pain full. 14Apr2021 she could not go to work again, she had no vomiting but continued with the on going dark liquid until 3:00 PM, she went to the bathroom and it was not liquid coming out of her rectum but a grey/taupe very soft stool. Her stomach area continued to hurt, she was still gassy. She only ate a banana, toast and Gatorade per the Dr. This was such a horrible experience. After the first shot she was praising the Pfizer Shot, now she would not. She did no really want the second shot after this experience. She was a new widow struggling, she had no one to help her, she had no phone as she had thrown up on her new phone and ruined it. This was such a terrible experience. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 56 | 2021-05-03 | inflammation of the pericardium, chest pain |
pericarditis; recurrent nonexertional, positional chest pain; SOB; dry cough with evidence of perica...
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pericarditis; recurrent nonexertional, positional chest pain; SOB; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; This is a spontaneous report from a contactable Physician. A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 01Mar2021 (at age of 56 years old) at single dose for COVID-19 immunisation. Medical history included Asthma. There were no concomitant medications. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (lot/batch number not provided) for COVID-19 immunisation, tioconazole and had Known allergies to Tioconazole. On 02Mar2021, the patient presented with recurrent nonexertional, positional chest pain, SOB (Shortness of breath) and dry cough with evidence of pericardial effusion and bilateral pleural effusions on CTA (Computerised tomogram). ECHO (Echocardiogram) confirming pericarditis. Labs and additional workup negative for AI or malignancy, all lab test in 2021. No. of days hospitalization was 2. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment received (Colchicine, Ibuprofen) for all events. The outcome of the events was Recovering. information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reassessed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 56 | 2021-05-04 | blood clot |
sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has bee...
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sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has been damaged or early stage of thrombosis; not sure if there was a nerve that has been damaged or early stage of thrombosis; severe arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Apr2021 at 09:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication was none. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 18Apr2021 at 18:00, the patient experienced severe arm pain that was described as arm pain was too painful and have been woken up out of her sleep and she has limited range of motion and she was not sure if there was a nerve that has been damaged or early stage of thrombosis. On 20Apr2021, the patient experienced sustain cramps in her right leg. The patient did not receive treatment for the events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 56 | 2021-05-07 | blood pressure decreased, fainting |
faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fev...
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faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry, start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-05-10 | chest discomfort, heart rate increased, loss of consciousness, blood clot |
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ...
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she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-02 | blood pressure increased |
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ...
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Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
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| 57 | 2021-01-03 | pallor |
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc...
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10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
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| 57 | 2021-01-03 | blood pressure increased, palpitations | I felt like I was having palpitations, and my blood pressure shot up to 169/119. |
| 57 | 2021-01-03 | blood pressure increased, fast heart rate | Numbs hands and feet, elevated blood pressure and tachycardia. |
| 57 | 2021-01-03 | palpitations |
Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after ...
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Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after vaccination and present continuously since vaccination date (12/21/20) to date of report (1/4/21). She notes that is has been present constantly and is worse at times but is not relieved despite use of ibuprofen, acetaminophen, naproxen, Excedrin Migraine, or eletriptan 40 mg dose. She states that this headache is similar to the headache she had with previous Covid infection in March 2020 and July 2020, which also was not relieved with any medications that she tried. Also reported heart palpitations awakening from sleep on 12/30/20. Advised to seek medical care from primary care provider. On 1/4/21 patient states that she believes headache is improving but is not resolved.
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| 57 | 2021-01-04 | loss of consciousness |
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio...
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01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
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| 57 | 2021-01-04 | pallor | Dizziness, Chills and Pale |
| 57 | 2021-01-04 | palpitations |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-04 | palpitations, chest discomfort |
I had most of side effects described. My ears hurt, like inside, but the most that bothers me today ...
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I had most of side effects described. My ears hurt, like inside, but the most that bothers me today is that my heart feels like its beating and racing fast, sometimes feels like its pounding. Very uncomfortable, my chest feels.
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| 57 | 2021-01-04 | palpitations |
I had most of the side effects listed, but the one that is still bothering me til this day is that m...
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I had most of the side effects listed, but the one that is still bothering me til this day is that my heart feels like its racing, beating fast and sometimes feels likes its pounding, very uncomfortable.
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| 57 | 2021-01-04 | blood pressure increased, palpitations |
Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes...
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Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.
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| 57 | 2021-01-04 | heart rate increased |
Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased predni...
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Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir. Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms
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| 57 | 2021-01-04 | heart rate decreased, chest pain, hypotension |
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure a...
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Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.
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| 57 | 2021-01-05 | nosebleed | Nosebleed |
| 57 | 2021-01-05 | palpitations, oxygen saturation decreased |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-05 | heart rate increased |
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn...
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Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
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| 57 | 2021-01-06 | hypertension |
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in...
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Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-06 | heart rate abnormal |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-07 | heart rate increased | Elevated heart rate, shortness of breath, headache |
| 57 | 2021-01-07 | nosebleed |
Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 5...
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Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EJ1685, via an unspecified route of administration on 04Jan2021 15:30 at single dose in right deltoid for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the Covid-19 vaccine on 04Jan2021 at 3:30pm. They monitored her for 30 minutes after she received it because she had allergies. After she got home she had a nose bleed on 04Jan2021. This morning (05Jan2021) at 5:00am she went downstairs to fix herself some food. She felt her nose running. She touched her nose with a paper towel and saw that it was bleeding. It was bleeding now. She had never had a nose bleed before. The patient had no lab tests. The outcome of the event "nose bleed" was not recovered, and of "she had allergies" was unknown.
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| 57 | 2021-01-07 | palpitations |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-09 | fast heart rate |
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr...
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Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
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| 57 | 2021-01-10 | blood pressure increased, transient ischaemic attack |
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev...
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experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 57 | 2021-01-11 | fibrin d dimer increased |
Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID va...
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Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.
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| 57 | 2021-01-11 | palpitations |
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a...
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pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
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| 57 | 2021-01-12 | hypertension |
Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen...
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Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen at 11:30 AM followed by 50mg of benadryl. Noted that patient had headache, nausea, high blood pressure, trouble breathing and went by ambulance to ER
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| 57 | 2021-01-12 | fast heart rate | severe tremors,tachycardia |
| 57 | 2021-01-14 | pallor |
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac...
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low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
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| 57 | 2021-01-15 | palpitations |
COMPLAINTS OF HEART RACING; 126/80; 104HR; 96%; 22 NL OBSERVED ADDITIONAL 15 MIN. REPEATT HR 98 SYMP...
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COMPLAINTS OF HEART RACING; 126/80; 104HR; 96%; 22 NL OBSERVED ADDITIONAL 15 MIN. REPEATT HR 98 SYMPTOMS RESOLVED
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| 57 | 2021-01-16 | blood clot |
Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood cl...
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Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood clots on my tongue
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| 57 | 2021-01-16 | heart rate increased |
Patient c/o rapid heart rate about 40 minutes after vaccination. HR was 140. No other symptoms--no C...
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Patient c/o rapid heart rate about 40 minutes after vaccination. HR was 140. No other symptoms--no CP, no SOB, no dizziness.
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| 57 | 2021-01-18 | palpitations, hypertension | Palpitations, high blood pressure requiring higher doses of meds. Still the BP is staying up. |
| 57 | 2021-01-18 | hypertension |
Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. W...
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Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. Was treated with a single dose of Dexamethasone 10 mg IV. Symptoms resolved and patient was sent home.
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| 57 | 2021-01-19 | chest pain |
Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup...
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Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup neg. Was advised that chest pain may be muscular pain from vaccine. Chest pain resolved. Continues to have fatigue, headache.
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| 57 | 2021-01-19 | palpitations, pallor |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-20 | heart rate increased, chest discomfort |
Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; So...
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Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
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| 57 | 2021-01-20 | hypertension, blood pressure increased | Elevated BP 200/120 known history of hypertension. Headache, Nausea and headache |
| 57 | 2021-01-20 | chest discomfort |
presented to vaccine clinic - received vaccination and while waiting - observer noted person was swa...
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presented to vaccine clinic - received vaccination and while waiting - observer noted person was swallowing frequently and asked if she was doing okay - she stated she felt a pressure in her chest "like my asthma" - relayed she thought she needed some Benadryl. Person was masked - observing staff asked for her to remove her mask and they noted where her mask was a pink to red outline of a fine rash. Person was subsequently taken to the ED for further evaluation and any needed treatment. ED notations: Patient is a pleasant 57 year old female with a history of asthma, eczema, obesity, LE edema presenting for vaccine reaction. Patient states she was upstairs at SCB getting her first COVID shot. She was sitting in the waiting area after receiving injection and noted to have sensation of chest tightness "similar to my asthma" within 10 minutes of receiving the vaccine. She was noted by nursing staff to also have redness to her face. Patient denied any difficulty breathing or swallowing, no raised rash/bumps to her face or body, no palpitations or fast heart rate, no swelling more than her usual baseline LE edema. She denies headache, feeling light headed, nauseous, or any symptoms of abdominal discomfort. Patient has a history of allergies to sulfa drugs and seasonal allergies, no food allergies/intolerances, or previous reactions to vaccines. Patient was determined to not be in anaphylactic shock but did have immediate symptoms after injection suggesting an allergic Type I hypersensitivity, redness and sensation in her chest improved with 50 mg of benadryl. The patient was reassured after an observational period of about 1 hour and no additional symptoms. She was notified that CDC guidelines are that even with a mild allergic reaction to the vaccine, that she should avoid getting the 2nd in series, continuing to practice other preventative measures against COVID, maintaining social distance and wearing a mask.
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| 57 | 2021-01-21 | fainting |
Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right uppe...
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Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right upper extremity. EMS called. Patient transferred to ER.
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| 57 | 2021-01-21 | chest discomfort |
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri...
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Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
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| 57 | 2021-01-21 | chest discomfort |
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/...
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received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
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| 57 | 2021-01-24 | chest discomfort |
Since receiving vaccine I have been having chest discomfort, but what's new is on Jan. 12, 2021, I s...
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Since receiving vaccine I have been having chest discomfort, but what's new is on Jan. 12, 2021, I started becoming SOB, while walking or doing simple tasks. Prior to vaccine I was fine, started symptoms after vaccine but SOB didn't happen right away, chest discomfort was there. Dds see my primary doctor on Jan. 18, prior to that I did see a doctor on Jan. 7, for chest discomfort that was bothering me. I was started on prednisone on Jan. 18, and to do neb tx at home.
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| 57 | 2021-01-25 | blood pressure increased | Episode of Nausea,Elevated BP 207/100 1 Hour following Vaccine administration |
| 57 | 2021-01-25 | palpitations, fast heart rate |
Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her hea...
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Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing. Patient was taken to the medic location. VS= 192/116, HR 152, O2 sat=99%
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| 57 | 2021-01-25 | hypertension, palpitations, chest pain, ischemic chest pain, fast heart rate |
Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCA...
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Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCARDIA, CHEST PAIN, AND SHORTNESS OF BREATH. TREATMENT AT ER/ HOPSPITALIZATION FOR TWO DAYS.
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| 57 | 2021-01-27 | chest discomfort |
Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat,...
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Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat, joint/muscle pain, nausea and abdominal discomfort with diarrhea. Fatigue, fever, joint/muscle pain began the next day. Shortness of breath, chest tightness, cough and sore throat started on the second day after receiving the vaccine. Fever resolved by day 3. Shortness of breath, chest tightness, sore throat and cough resolved on the 6th day. Fatigue, muscle/joint pain resolved by day 7. Developed nasal congestion by day 5 which resolved on day 10. Treatment was rest, fluids, Tylenol, and Claritin.
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| 57 | 2021-01-27 | blood clot |
Patient experienced a blood clot on January 11th. She is unsure if it is related to the vaccine or n...
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Patient experienced a blood clot on January 11th. She is unsure if it is related to the vaccine or not.
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| 57 | 2021-01-27 | fast heart rate, chest discomfort, pallor |
Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed ...
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Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed and she experienced tachycardia for several minutes. Pulse was not checked. She then became extremely pale, light headed, and sick for 10-15 minutes. Chest was heavy in the evening from 8-9 pm so she took an antacid and went to bed. She woke up at 11pm, but body was still sleeping and she couldn't move. She has never experienced this before. Arm was very sore, but has improved. Has also been taking ibuprofen and Tylenol for body aches.
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| 57 | 2021-01-27 | pallor |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-28 | blood pressure increased, chest discomfort | Chest pressure in middle of chest and around back. Blood pressure went high. Went to er |
| 57 | 2021-01-28 | oxygen saturation decreased |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | heart rate increased |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-30 | chest pain | right arm pain radiating into right anterior chest |
| 57 | 2021-01-31 | chest discomfort |
Started with temp on Monday night 103.8, headache, chills, dizziness, sweats, fever, flutter in my c...
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Started with temp on Monday night 103.8, headache, chills, dizziness, sweats, fever, flutter in my chest off and on. Got worse Tuesday with the same symptoms. Took Ibuprofen to help with fever. Wednesday went to ER with flutter in chest. Was Frequent PVC?s. Had fever, headache, and dizzy until Sunday. So far today Monday 2-1-21 no fever just dizzy and flutter in chest off and on.
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| 57 | 2021-02-01 | hypertension |
Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of...
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Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-02 | hypertension | Weak, Tremor, Dizzy, Hypertensive |
| 57 | 2021-02-04 | loss of consciousness |
I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and ...
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I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and when I was in my bathroom, I collapsed. I do not remember actually falling but I heard the thud when I hit the floor. I tried to get up and had absolutely no strength in any part of body. My husband came to help me up but I could not even lift up my head. He was finally able to help me up and I took a few steps and collapsed/fainted again. This has never happened to me in my life.
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| 57 | 2021-02-04 | palpitations, chest discomfort |
Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 1...
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Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 12min post-vaccination patient developed throat tightness/itching. 0.3mL epinephrine auto-injector was administered at the vaccination site and the patient was transported to the emergency department for further treatment. Patient reported epinephrine made her symptoms worse. Emergency Department provider diagnoses symptoms as anxiety and gave a dose of lorazepam which improved the patient's condition. The patient was discharged from the ED after being monitored for 4 hours with improvement in symptoms. No further treatment was given.
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| 57 | 2021-02-05 | palpitations |
Heart began racing suddenly, to about 120-140 bpm. No shortness of breath, chest pain, sweating or a...
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Heart began racing suddenly, to about 120-140 bpm. No shortness of breath, chest pain, sweating or any other symptoms. Lasted approximately 2-3 minutes after which heart rate returned to normal (72-76 bpm).
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| 57 | 2021-02-07 | chest pain |
At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 10...
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At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 101.6 F. Pt had fever for 24 hours. She took Tylenol at that time. Her face was also red after the second vaccine and has remained red around the lower half of her face. Her face tingles at times. She feels like bugs are walking on her face and body at times, get itchy at times, gets hot, then gets cold. Pt felt a zap like electricity in her bosom for on 1 day in her left breast/ chest fleetingly. She feels it, zaps, sometimes in other places in her body since then rarely, not daily.
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| 57 | 2021-02-07 | chest discomfort | Pt reports chest tightness, tongue numbness, normal EKG. Pt recovered |
| 57 | 2021-02-07 | palpitations |
Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, w...
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Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw, couldn't catch my breath with mask on. I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count. I quickly took my coat off. I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on. Pulse was down to 80 bpm. The skin on my face and neck felt like they were burning. The tip of my tongue felt tingly. All subsided until next day, felt fluish, temp 101.5.
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| 57 | 2021-02-07 | chest pain | SOB with chest pain, headache |
| 57 | 2021-02-07 | chest discomfort |
Ten minutes after the vaccine was administered the patient started with a persistent nonproductive c...
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Ten minutes after the vaccine was administered the patient started with a persistent nonproductive cough, hoarseness, chest tightness, shortness of breath. Vital Signs BP 128/77: P=96: R=19: O2 sat=100% Oxygen was administered by nasal cannula, Solumedrol 125mg IV and nebulizer therapy with Atrovent 0.2 x 1. Was kept under observation and after one hour the patient had recovered. Per the patient.
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| 57 | 2021-02-07 | heart flutter, cardiac arrhythmia |
The evening of the vaccine, patient experienced typical symptoms, but also fluttering in chest. Two ...
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The evening of the vaccine, patient experienced typical symptoms, but also fluttering in chest. Two days later patient still had cardiac flutter and presented to the emergency department where she was found to have frequency PVCs and hypokalemia. Patient was instructed to follow up with her cardiologist and reports still having dizziness and chest fluttering on 1/31/21
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| 57 | 2021-02-08 | heart rate increased |
20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both a...
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20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped spreading and improved heat rate and B/P. Was released to go home by EMT. While traveling home had to stop by roadside because of vomiting and nausea. Next morning rash still present on arms and fingers.
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| 57 | 2021-02-08 | heart rate increased | Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911. |
| 57 | 2021-02-09 | chest discomfort, blood pressure increased, heart rate increased, fast heart rate |
On Dec 31, 2020 I began having pressure in chest, neck and headache and rapid heart rate. Normal B/P...
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On Dec 31, 2020 I began having pressure in chest, neck and headache and rapid heart rate. Normal B/P was now 150's/ diastolic 100's for 7 days. Saw PCP, referred to Cardiologist. Had Echo, EKG and stress test. EKG changes noted, "probably normal" stress test. B/P normalized by January 7 2021, tachycardia improved January 9. Missed several days of work due to symptoms.
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| 57 | 2021-02-09 | fast heart rate |
Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous r...
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Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
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| 57 | 2021-02-09 | chest pain |
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ...
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her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
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| 57 | 2021-02-10 | hypertension |
Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left ...
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Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | palpitations |
Throat itchy, heart racing, feeling sensation throughout my body and feeling very faint within 5 mi...
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Throat itchy, heart racing, feeling sensation throughout my body and feeling very faint within 5 mins from injection. The Dr on call and nurse or PA gave me benadryl and checked my vitals twice. The itchy feeling went away after about 15/20 mins. My vitals were normal both times. I have had anxiety/panic attacks in the past, but this felt different. I stayed total 45 mins to make sure no other reaction occurred.
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| 57 | 2021-02-10 | hypertension |
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some t...
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Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some tingling in her extremities. EMS evaluated patient on-site. Patient was instructed to remove her mask and take deep breaths to settle her anxiety. Patient was hypertensive (175/104), SPO2 97%, and a FSBG of 95mg/dl. Several minutes later, the patient reported a return of dizziness and tingling. EMS obtained a 12-lead EKG that was unremarkable. Patient refused transport to the hospital.
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| 57 | 2021-02-10 | palpitations |
Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing a...
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Within in minutes I had a strong metallic taste in mouth and order in nasal passages. Heart racing and lightheaded. I was given water, observed, and told to call for a ride. Felt better in 15 - 20 min. was tired rest of the day.
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| 57 | 2021-02-10 | palpitations | lip tingling, dizziness, heart racing had hives 24-48 hours after 1st dose |
| 57 | 2021-02-10 | body temperature decreased |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-12 | blood clot |
Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CH...
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Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:
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| 57 | 2021-02-14 | chest pain |
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain...
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Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
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| 57 | 2021-02-18 | chest pain |
* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe mig...
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* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe migraine with some nausea during night, and lasted all day Saturday (~20 hrs.) I took Children's Tylenol dye free liquid late in day which took slight edge off headache. * Developed severe central chest pain in night, which felt like pain I experienced with esophagitis/gastritis in past. This lasted for about 20-30 minutes, then resolved. * Awoke next morning (Saturday, 1/9/21) with low grade fever (~99.3 degrees F), and had fever for 2 days (never exceeded 100.3 degrees F that I detected)--no appetite all day * Developed central low back pain/ache on Saturday ~ mid-day, which lasted through at least Sunday * Awoke Sunday morning with rash on torso (same rash familiar to me when I have infections--biopsied in past and determined to be interface dermatitis). Rash progressed throughout day to portion of arms, neck, groin (as always does with illness), and faded until resolving Monday am/mid-day. Itching then occurred over next couple of days (as it always does with illness). Appetite still limited. * Sunday evening experienced acute abdominal pain and urgent diarrhea x 3 or 4 episodes * Monday I felt better, but was fatigued and trying to get back on my feet
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| 57 | 2021-02-21 | hypotension, heart rate increased | Rapid heart rate Burning through body Cold sweat Felt low blood pressure |
| 57 | 2021-02-22 | pallor |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-23 | lightheadedness, palpitations |
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;...
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I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-02-23 | chest pain |
Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck,...
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Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.
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| 57 | 2021-02-23 | heart attack |
The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was r...
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The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was raw) and bleed for a few days; I felt like I was having a heart attack; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunisation. The patient's medical history included asthma and known allergies to medication. Concomitant medications included paracetamol (TYLENOL) and metoprolol, which were reported as medications in two weeks. It was reported that other vaccines in four weeks were prescribed. On 31Jan2021 at 09:00 AM, the patient experienced the roof of her mouth shedded (was raw) and bled for a few days. A few days later (2021), she felt like she was having a heart attack. There was no treatment for the events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovered on 2021. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-23 | chest pain |
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area...
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arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
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| 57 | 2021-02-26 | hypotension, pallor |
Immediately after being vaccinated the patient requested to lie on the floor because she felt dizzy....
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Immediately after being vaccinated the patient requested to lie on the floor because she felt dizzy. RN place patient in a reclining position and requested evaluation of patient by NP.Patient was pale, and diaphoretic.Patient denied chest pain, SOB, N/V, negative rash, negative facial swelling,Pt was Hypotensive.EMS was activated .Repeat V/S 3 minutes later were WNL pt remained A&O throughout encounter.Pt stated " this has happened before". Patient was transported to Hospital Via EMS
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| 57 | 2021-03-03 | blood pressure increased, heart rate increased |
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of...
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Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
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| 57 | 2021-03-04 | loss of consciousness, blood pressure decreased |
The patient went unconscious and was having slight involuntary muscle jerks while on dialysis. The p...
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The patient went unconscious and was having slight involuntary muscle jerks while on dialysis. The patients blood pressure dropped to 63 systolic. Shortly after a 500ml saline bolus, patient stabilized. Patient left on ambulance by request. This is not believed to be an allergic reaction to the vaccine, but due to the timing, is being reported as an adverse event for review.
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| 57 | 2021-03-06 | palpitations, cardiac arrhythmia, fast heart rate | Palpitations, PAC, PVC, tachycardia, 2 hours and then extended off and on for 2 weeks |
| 57 | 2021-03-06 | hypertension |
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt...
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Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
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| 57 | 2021-03-07 | pallor |
1:37PM PT IN PASSENGER SEAT OF HER VAN. VERY SOB. SQUAD CALLED. STATES SHE GOT COVID VACCINE, WAIT...
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1:37PM PT IN PASSENGER SEAT OF HER VAN. VERY SOB. SQUAD CALLED. STATES SHE GOT COVID VACCINE, WAITED 15MIN WITHOUT ANY PROBLEMS. WALKED OUT TO VAN AND BECAME VERY SOB AND HAS NOT BEEN ABLE TO RECOVER. ON PERSONAL 02/NC. A/O, PALE, W/D WITH MOD RESP DISTRESS. 1:45PM TRANSPORT TO ER PER SQUAD. STATES SHE WAS TO HAVEA LUNG SCAN TODAY AT 2PM. 3-5-21 4:30PM TC - STATES SHE WASTX AND RELEASED 3-4-21 AT 11PM WAS GIVEN LASIX 120MG AND HAD LUNG SCAN. STATES SHE DOES FEEL BETTER TODAY. ALL S/S RESOLVED.
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| 57 | 2021-03-07 | loss of consciousness |
Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered with...
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Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered within a few minutes Transported to the hospital via ambulance and monitored at the hospital for about an hour after that.
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| 57 | 2021-03-07 | haemoglobin decreased |
Vaccine received from off site facility. Unknown site or lot number. Patient started to experience...
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Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.
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| 57 | 2021-03-08 | chest pain |
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain...
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Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
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| 57 | 2021-03-08 | blood pressure increased, chest pain |
hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, ...
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hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain, vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and taste, tingly limbs gone but severe pain behind right knee, ruled out blood clot, smell back, taste not all the way returned, pain continuous
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| 57 | 2021-03-09 | hypertension |
Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/...
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Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/p-158/90. I was lightheaded and thought I was going to pass out. My blood pressure has never been that high. Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.) This lasted about 8 min and then my HR started to go back down.
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| 57 | 2021-03-09 | hypertension, chest pain |
Dizzy, elevated BP. Her other vitals were normal. Pt was disoriented. Had taken BP meds that morni...
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Dizzy, elevated BP. Her other vitals were normal. Pt was disoriented. Had taken BP meds that morning, had not eaten food since previous evening. During time pt was being monitored approx 45mins, she became nauseous, SOB, lightheaded and had chest pain with exertion.
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| 57 | 2021-03-09 | heart rate increased |
at 11 hours past the vaccination time (COVID #2) I developed a rapid heartbeat > 90 and body aches. ...
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at 11 hours past the vaccination time (COVID #2) I developed a rapid heartbeat > 90 and body aches. They intensified 18 hours later and lasted another 24 hours. I also had dry heaves(once only) and loose bowels. I am diabetic and my sugars also went crazy. I had to visit my cardiologist for an EKG to make sure there wasn't a problem with my heart. I had to call my diabetes doctor several times for help with how to handle my numbers.
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| 57 | 2021-03-10 | hypotension |
57 year old female who was seen today for her second dose of the COVID 19 vaccination. She was g...
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57 year old female who was seen today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes. PMH: prediabetes, copd. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days. Objective Vitals Vitals: 03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm Patient Position: Sitting Pulse: 97 90 SpO2: 96% 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Pepcid and Zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching. She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with Benadryl use. Pt voiced appreciation of her care today. PT walked out by pharmacist.
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| 57 | 2021-03-10 | hypotension |
Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the C...
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Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes. PMH: prediabetes, copd. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days. Objective Vitals Vitals: 03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm Patient Position: Sitting Pulse: 97 90 SpO2: 96% 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines pepcid and zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching. She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with benadryl use. Pt voiced appreciation of her care today. PT walked out by pharmacist.
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| 57 | 2021-03-10 | palpitations, heart rate increased |
Patient stated that she felt light headed and could feel her heart pounding. Patient was diaphoretic...
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Patient stated that she felt light headed and could feel her heart pounding. Patient was diaphoretic and had a rapid pulse. Patient was taken to recovery via wheelchair to lay down on cot, an ice pack was placed on the back of her neck. Patient stated that she felt better after 20 minutes and walked to her car without incident.
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| 57 | 2021-03-11 | palpitations, heart rate increased |
First dose I felt go to my heart 20 min after getting it. Second dose day after receiving had very r...
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First dose I felt go to my heart 20 min after getting it. Second dose day after receiving had very rapid heart rate and hard pounding
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| 57 | 2021-03-12 | pallor |
Less than 10 minutes following injection, patient complained of feeling lightheaded like she was goi...
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Less than 10 minutes following injection, patient complained of feeling lightheaded like she was going to pass out. On exam of patient in passenger seat of car, patient found to be slumped over pale, diaphoretic but responsive. Patient when asked stated she is a diabetic and has an insulin pump. Blood sugar was 111. Patient stated she had reacted to other medications in the past. No respiratory distress noted, no rash or hives. Patient was informed that we felt she should be evaluated in ER. Patient and husband both agreed. Patient transported to ER via wheelchair. Patient immediately placed on cardiac monitor, rhythm normal sinus without ectopy. Husband at bedside. Patient treated with zofran and was feeling some better. Lab work returned within normal ranges.
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| 57 | 2021-03-12 | palpitations |
Racing heart, elevated heart rate within 15 minutes Chills, feverish within 2 hours Fatigue same day...
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Racing heart, elevated heart rate within 15 minutes Chills, feverish within 2 hours Fatigue same day and entire next day Swelling at injection site within 12 hours
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| 57 | 2021-03-14 | lightheadedness |
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin...
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11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
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| 57 | 2021-03-14 | pallor, loss of consciousness |
Patient received 2nd Covid vaccine on 2/19/2021, shortly after patient states she did not feel well,...
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Patient received 2nd Covid vaccine on 2/19/2021, shortly after patient states she did not feel well, like she was going to faint. Patient became pale, diaphoretic, pupils dilated and was unresponsive. I stayed with patient and supported her head/airway as she was seated in a chair. Dr. arrived, ED staff arrived and stretcher arrived, patient started to wake up and we assisted her to sit on the stretcher. Patient was alert , talkative and her color was better. She had a small emesis x2. Patient then laid down on the stretcher and stated she was feeling better. Patient was taken to the ED via stretcher, she was alert and responsive.
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| 57 | 2021-03-16 | hypertension, fast heart rate |
About 10 minutes after vaccine given, patient began to experience tachycardia, lightheadedness and a...
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About 10 minutes after vaccine given, patient began to experience tachycardia, lightheadedness and a headache. Vitals showed heart rate within normal limits, slight hypertension. Patient took Xanax shortly before her vaccine. Symptoms resolved.
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| 57 | 2021-03-16 | chest discomfort |
Experienced intense chills, inability to maintain body temperature, headache, body ache. These sympt...
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Experienced intense chills, inability to maintain body temperature, headache, body ache. These symptoms intensified over a course of 3-4 days. Symptoms were most severe on the 3rd night -- in addition to chills and aches, experienced difficulty breathing, tightness in chest, vomiting. Treated with bed rest and Tylenol. Consulted family physician on the 4th day.
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| 57 | 2021-03-16 | heart rate increased, blood pressure decreased |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-16 | lightheadedness | Patient complained of dizziness, abdominal pain, nausea, and near syncope. |
| 57 | 2021-03-16 | fainting |
Patient was sitting in waiting area post vaccination. A pharmacist from the vaccination area was ca...
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Patient was sitting in waiting area post vaccination. A pharmacist from the vaccination area was called over to her because she was not feeling well. As the pharmacist was speaking with her patient fainted. Pharmacist was holding on to her to keep her from falling. I went over and took her BP which was 65/44, pulse 53. After a few minutes patient regained consciousness and was able to give us her information. 911 was also called. Patient reports a history of severe reaction to Penicillin. Patient reports history of syncope at eye doctor's office. Her BP was taken again at 10:20am and was 98/72, pulse 70. 911 arrived and patient chose to be taken to hospital.
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| 57 | 2021-03-16 | palpitations, chest pain |
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days af...
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Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
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| 57 | 2021-03-18 | heart rate irregular |
Injection at 11:15AM. Guest reported to staff feeling "throat tightening", HTN 150/90, HR irregular...
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Injection at 11:15AM. Guest reported to staff feeling "throat tightening", HTN 150/90, HR irregular. Guest reports not taking B/P meds this AM. EMT called and responded within 3 minutes. Guest reported improvement of throat tightening. Guest reported anxiety of needles and reported lightheadedness. At 11:24 B/P 142/92, HR 115, )2 Sat 97%. Guest's son came to get the client.
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| 57 | 2021-03-18 | fast heart rate |
Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). P...
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Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). Pepcid 20mg PO(1.30pm)., Tylenol 1g PO (1.56pm). Observation for 1hr, HR reduced to 92. Able to drink and swallow meds. HA & lightheadedness resolved and mild dysphagia, HR 82 at 3.13pm.
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| 57 | 2021-03-20 | skin turning blue | Bilateral cyanosis of feet occurring about 3-5 days after 2nd dose. |
| 57 | 2021-03-21 | chest discomfort |
21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, w...
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21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, wheezing, voice became barely audible. Coughing. At 1830, 30 min post injection, EMTs administered IM epinepherine, 25 mg IV Benadryl, 1 albuterol neb. At 1851 on ER arrival, BP 206/87, pulse 95, resp 18, temp 97.5 F, SpO2 99%. At 1913, attending physician administered solumedrol 125 mg. At 1755, blood drawn for total complement, CH50, and tryptase At 2240 improved, stable, discharged from ER with instructions to take 50 mg oral prednisone for next two mornings and follow up with primary care physician as necessary
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| 57 | 2021-03-21 | chest pain | 3 DAYS AFTER VACCINE PATIENT DEVELOPED HIVES, CHEST PAIN AND THROAT SWELLING. |
| 57 | 2021-03-21 | chest discomfort |
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a...
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About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in lips. We moved her to the floor and laid her flat with head raised as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was called. Rescue squad arrived stabilized her and transported to hospital.
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| 57 | 2021-03-21 | hypertension | High BP variation and sodium level dropped |
| 57 | 2021-03-21 | nosebleed |
I began to have several very severe nose bleeds starting Saturday and into Sunday night. It was not...
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I began to have several very severe nose bleeds starting Saturday and into Sunday night. It was nothing I had ever experienced. It took 30 minutes to an hour to get them to stop. Then it would randomly start again. Just sitting quietly and it would start again. I am hoping they do not continue into today. I have had one real nose bleed in my life and it was a broken nose. These were as bad if not worse than the broken nose. During the time when I was trying to stop them, huge clots would form but they would just fill the gap and the blood would drain out the other side or down my throat and into my mouth. Soon the clots would get a little smaller and finally After getting the clots all out it would finally subside.
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| 57 | 2021-03-21 | chest discomfort |
Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient...
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Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient was complaining of chest tightness, throat closing sensation, "weird" feeling over body.
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| 57 | 2021-03-21 | chest discomfort, chest pain |
Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. ...
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Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. Shortness of breath. Pain when trying to take deep breath. The shoulder, chest and back pain was unbearable for seven days
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| 57 | 2021-03-21 | blood glucose increased |
She complained of a scratchy throat. On site EMS was called vitals BP 153/99 HR 80 99% O2 GB 113 mg....
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She complained of a scratchy throat. On site EMS was called vitals BP 153/99 HR 80 99% O2 GB 113 mg. She was given Diphhenhydramin 25 mg orally. She was released to go home.
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| 57 | 2021-03-23 | palpitations |
Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue ...
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Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue thickness, "feels weird". Macular Rash mid sternum noted by on site physician. No respiratory distress noted. No epinephrine administered.
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| 57 | 2021-03-23 | hypotension, fainting |
Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension...
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Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
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| 57 | 2021-03-23 | fainting, chest discomfort |
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: F...
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Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
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| 57 | 2021-03-23 | hypotension, fainting, loss of consciousness |
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension...
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient lost consciousness for ~1 minute, around 5 minutes after receiving first dose of Pfizer COVID-19 shot. Patient was spotted by other patients in waiting area and nearby technician immediately. Breathing never stopped, no epinephine/benadryl administered. Patient was sweating and was provided water. As soon as she regained consciousness, she was able to recite her name and DOB. 911 was called and paramedics arrived within 5 minutes. Taken by EMS to ER.
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| 57 | 2021-03-23 | chest pain | dizziness and itching....progressed to anxiety and chest pain. |
| 57 | 2021-03-23 | chest discomfort | throat and chest tightening, severe headache, dizzy |
| 57 | 2021-03-24 | fainting |
5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began t...
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5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began to complain of dizziness, weakness, fatigue and nausea. Patient had rapid breathing and stated she was scared. EMS staff addressed patient and began to assess her when she vomited and had a brief syncopal episode. She was taken to a private area and was monitored. All vital signs repeated, EKG done, Patient was given IV fluids and antiemetic, and the transferred to ED. Patient was alert and oriented with vital normal vital signs upon transfer.
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| 57 | 2021-03-24 | lightheadedness | Nausea and vomiting, lightheadedness, vasovagal reaction |
| 57 | 2021-03-24 | heart rate increased |
Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred w...
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Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred within 5 mins of getting vaccine, lasted A couple minutes. Should I not get the 2nd vaccine?
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| 57 | 2021-03-25 | lightheadedness, heart rate increased, blood pressure increased |
Blood pressure and heart rate increased to 163/100 and heart rate was 105. I almost passed out and w...
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Blood pressure and heart rate increased to 163/100 and heart rate was 105. I almost passed out and was very dizzy and disoriented. Fatigue for 7 days and heart rate is still elevated. Also experienced green bulging veins in hands and feet.
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| 57 | 2021-03-25 | palpitations | Racing Heart beat, Hot Flash no fever, muscle aches and cramps, feeling unwell |
| 57 | 2021-03-26 | palpitations, heart rate increased |
4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching o...
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4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching on left arm near wrist, arm where shit was. etc., For next 3 hours. Took antihistamine chlortrimitron 2, mucinex 1, drank water. 6pm, hbm 87, 78, felt like palpations, throat more swollen. Kept clearing throat to keep open. 9pm, bm 82, 78, 93, throat not worse, drank water. With heart rate so high, I didn't take epipen. 9:10pm went to bed 12am woke up throwing up intensely. Took prescription promethazine let dissolve in mouth, went to bed. 9am woke up with little nausea, light headache, swollen raw throat. 4:30pm, 25+ hours after shot, throat still really swollen, arm sore, tired.
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| 57 | 2021-03-26 | chest discomfort | chest tightness, pt thought anxiety related |
| 57 | 2021-03-27 | blood pressure increased |
8 days after first vaccine, woke up with extreme vertigo. Dizziness , diarrhea, nausea continues t...
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8 days after first vaccine, woke up with extreme vertigo. Dizziness , diarrhea, nausea continues to present. Went to urgent care and was diagnosed with vestibular problems and referred for vestibular rehabilitation. Blood pressure is elevated despite medications.
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| 57 | 2021-03-27 | chest pain |
left scars to her left breast still, that look like white crust on them/scars on her left breast; le...
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left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
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| 57 | 2021-03-29 | atrial fibrillation, heart rate increased | Fast heart rate/ atial Fib went to the emergency on 3/8/2021 at 8pm |
| 57 | 2021-03-30 | pulmonary embolism |
Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contras...
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Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contrast; Shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En5318), via an unspecified route of administration, administered in left arm on 04Feb2021 10:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3249) administered on the left arm on 14Jan2021 10:00 AM for COVID-19 immunization. The patient was diagnosed in Emergency room (ER) with 4 subsegmental pulmonary embolisms on 18mar2021 16:00 shown with CT scan with contrast and experienced shortness of breath on 18Mar2021 16:00. Prior to vaccination, the patient was not diagnosed with COVID. Patient was tested COVID post vaccination. The patient underwent lab tests and procedures which included CT scan with contrast: 4 subsegmental pulmonary embolisms on 18Mar2021, and nasal swab: negative on 14Jan2021. Therapeutic measures were taken as a result of the events and included treatment with apixaban (ELIQUIS). Facility type vaccine was Nursing Home. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, life threatening illness (immediate risk of death from the event). The outcome of the events were recovering.
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| 57 | 2021-04-06 | hypertension |
Around 48 hours after vaccination, blood pressure was very high, 173/105; This is a spontaneous repo...
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Around 48 hours after vaccination, blood pressure was very high, 173/105; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 19Mar2021 12:30 as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Medical history included hypertension which was controlled and never had it been over 155/98. The patient had no known allergies. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), losartan, and sertraline. On 21Mar2021 at 12:15 PM, around 48 hours after vaccination, blood pressure was very high, 173/105. Contacted doctor a took 2 additional dosage of losartan 25 mg. Two hours after 3rd pill BP was 192/114. The patient had not consumed salt or alcohol and did not have any preoccupations or anxiety. The event caused hospitalization on an unspecified date. The event resulted in emergency room and physician office visits. Therapeutic measures were taken as a result of the event includes had electrocardiogram (EKG) and waited more time until losartan lower. On an unspecified date, the patient recovered from the event.
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| 57 | 2021-04-08 | loss of consciousness |
PATIENT REPORTS BEING IN A PARKING LOT 2.5 HOURS AFTER RECEIVING VACCINE AND BLACKING OUT AND WHEN S...
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PATIENT REPORTS BEING IN A PARKING LOT 2.5 HOURS AFTER RECEIVING VACCINE AND BLACKING OUT AND WHEN SHE CAME TO, SHE WAS IN THE HOSPITAL AFTER HAVING TO HAVE CHEST COMPRESSIONS FOR 30 MINUTES TO BRING HER BACK. AFTER HOSPITAL EVALUATION, THE ONLY THING THE HOSPITAL COULD ATTRIBUTE HER EPISODE TO WAS THE VACCINE AS NOTHING ELSE SHOWED ON LAB WORK AND EXAMINATION AND PATIENT DID NOTHING ELSE DIFFERENTLY.
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| 57 | 2021-04-09 | heart flutter |
face and chest turned "really red"/get real bright red like a tomato/her chest and face were bright ...
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face and chest turned "really red"/get real bright red like a tomato/her chest and face were bright red; felt some fluttering later in the evening/flutters in pacemakers; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via intramuscular route, administered in right arm on 05Mar2021 at 03:30, at the age of 57 years, at a single dose for COVID-19 immunization. Medical history included pacemaker placed 20 years ago to prevent her from easily passing out, during surgery they punctured heart wall and she started bleeding out into her heart wall and they had to do surgery and relief the bleeding in her heart, she has fought pericarditis ever since. The patient was allergic to sulfas. There were no concomitant medications. It was reported that 20 minutes after receiving the first dose of the vaccine, at 03:50, the patient's face and chest turned "really red." She had no other symptoms and did not notice the redness until her husband pointed it out. She was fine and then get real bright red like a tomato. They were concerned, stated there were no hives, just her chest and face were bright red. They called the paramedics and recommended Benadryl but she did not take any, states when they got home and settled down, it disappeared. As patient was allergic to sulfas, she waited 30 minutes not 15 minutes. Patient has had a pacemaker for 20 years, and felt some fluttering later in the evening after the first shot (05Mar2021) but it went away. The patient was nervous about this afternoon (26Mar2021) as she was getting the second shot, hence the reporter was seeking guidance on what do to about the second dose. The events were reported as non-serious, and did not require a visit to the emergency room nor the physician's office. The events recovered on 05Mar2021. Information on lot/batch number has been requested.
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| 57 | 2021-04-12 | blood pressure increased |
Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes a...
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Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
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| 57 | 2021-04-12 | chest pain |
Patient received 1st dose of Pfizer COVID vaccine on 3/31/21. Patient developed COVID symptoms ~ 4/3...
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Patient received 1st dose of Pfizer COVID vaccine on 3/31/21. Patient developed COVID symptoms ~ 4/3 and tested positive for COVID on 4/9/21. Patient was exposed to someone who was also found to be COVID positive. Patient presented to the ER with fever, cough, congestion, chest pain, body aches, and shortness of breath on 4/10/21 and was admitted to the hospital for COVID treatment.
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| 57 | 2021-04-13 | atrial fibrillation, troponin increased, heart attack, inflammation of the heart muscle |
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Ex...
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Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Excess saliva. As the pain persisted the pain radiated to the left arm/shoulder. We sought help at our local emergency department where she was found to be in new onset atrial fibrillation. A battery of tests were ordered including a troponin which was noted to be: 1.48. She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
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| 57 | 2021-04-15 | fainting | Syncope event Vertigo |
| 57 | 2021-04-15 | loss of consciousness | Wife found unconscious on kitchen floor. |
| 57 | 2021-04-17 | atrial fibrillation |
Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 57-year-...
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Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (Lot Number: ER8733), at the age of 57-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included High blood pressure. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; amoxicillin taken for an unspecified indication, start and stop date were not reported. On 29Mar2021 12:15, the patient experienced atrial fibrillation 4 days after injection. The event includes emergency room visit and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the event was unknown. Therapeutic measures were taken as a result of the event which includes IV medication.
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| 57 | 2021-04-17 | vaginal haemorrhage |
Post menopausal bleeding; vaginal bleeding; This is a spontaneous report from a contactable physicia...
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Post menopausal bleeding; vaginal bleeding; This is a spontaneous report from a contactable physician (patient) reported for herself. A 57-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9266, expiration date unknown) via unspecified route of administration at arm right on 16Feb2021 16:15 at age of 57-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hypertension, allergic to Cipro. Patient previously received 1st dose of BNT162B2 on 21Jan2021 at 02:00 PM (Lot number: EL3246) at single dose for COVID-19 immunisation. Concomitant medications included lisinopril, biotin/ cyanocobalamin/ folic acid (MVI 3), vitamin D3. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP 7/2018 No significant gynecological history other than pregnancies/childbirth. No prior abnormal vaginal/uterine bleeding. No known history pf uterine fibroids. No h/o bleeding/coagulation disorder. On 18Feb2021, patient experienced vaginal bleeding began with light flow and gradually increased with use of pads and tampons. There was no clots. Menstrual period lasted until 23Feb2021. (This appeared to be similar to menstrual periods in the past except there was no cramping on the first day and in the past would have expected to end on 22Feb2021. No further vaginal/uterine bleed or spotting since 23Feb2021. On 19Feb2021, platelet was 349 (normal range: 150-450). On 16Mar2021, endometrial biopsy was negative. On 16Mar2021, Pap (Smear cervix) was negative. On 16Mar2021, ultrasound showed endometrial thickness within normal range 4 mm, 2 small fibroids 1 cm, 2 cm, normal ovary sizes, small L ovarian cyst. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 by COVID-19 PCR (SARS-CoV-2) saliva with unknown results. It was reported that patient experienced Post menopausal bleeding on 18Feb2021 at 12:30 and vaginal bleeding on 18Feb2021 at 12:30. Outcome of events was recovered on 23Feb2021. Events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events.; Sender's Comments: Based on the information provided, reported events are not related to suspect product. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-04-17 | skin turning blue, blood clot |
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ...
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tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
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| 57 | 2021-04-19 | cardiac arrest |
Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and se...
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Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and sedation. After admission, the patient experienced cardiac arrest.
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| 57 | 2021-04-24 | platelet count decreased |
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop i...
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Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 57 | 2021-04-24 | fainting |
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p...
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possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
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| 57 | 2021-04-24 | ischemic chest pain, palpitations |
symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart pa...
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symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-04-25 | chest discomfort | After 10min chest felt tight , started to wheeze , throat started to swell , coughing a lot |
| 57 | 2021-04-28 | cerebrovascular accident |
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe ge...
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Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-04-30 | hypotension |
Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; Th...
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Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-04-30 | blood pressure increased |
She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness o...
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She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered. No Follow-up attempts are needed. No further information expected.
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| 57 | 2021-04-30 | blood clot |
headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial bloo...
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headache; nausea; light headed/ dizziness; unsteady gait; vomiting; chills; sweats; superficial blood clot; pain to back of Rt knee; bruising; swelling; This is a spontaneous report from a contactable Nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, administered in Arm right on 31Mar2021 (Batch/Lot Number: EW0150) (at age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included osteoarthritis, and migraines. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2, intramuscularly, administered in left Arm on 10Mar2021 (at age of 57-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was unknown if other vaccine in four weeks. It was unknown if COVID prior vaccination. The patient experienced onset of pain to back of Rt knee, bruising, and swelling on 06Apr2021. She called doctor on 09Apr2021, provider diagnosed her with superficial blood clot. Treating with applying warm compress to area. Client had onset of headache, dizziness, nausea, light headed, unsteady gait, vomiting, chills and sweats on 10Apr2021. Patient called doctor on 14Apr2021, they recommended covid-19 testing, results are negative on 12Apr2021. Symptoms ongoing since 14Apr2021. The outcome of events was not resolved.; Sender's Comments: Based on plausible temporal association, a causal association between the reported event thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-05-03 | palpitations, heart rate increased, chest discomfort | short of breath extremely fast heart palpitations fast pulse chest discomfort |
| 57 | 2021-05-04 | excessive bleeding, vaginal haemorrhage |
tired; it was spotting like bleeding it looks like bleeding; I had prompt pain/ body ache; I had Spo...
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tired; it was spotting like bleeding it looks like bleeding; I had prompt pain/ body ache; I had Spotting; I have gone to menopause; my cycle has stopped; slept; I felt chill; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 57-years-old) in Arm right on 10Apr2021 (Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included high blood pressure and menopause. Concomitant medications included losartan potassium and hydrochlorothiazide; both taken for hypertension, paracetamol (TYLENOL) taken for prophylaxis ("before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain"), and unspecified vitamins; start and stop dates were not reported. The patient experienced "it was spotting like bleeding it looks like bleeding" on 11Apr2021, "I felt chill" on 10Apr2021, "I had prompt pain/ body ache" on 11Apr2021, "I had spotting; I have gone to menopause; my cycle has stopped" on 11Apr2021, "slept" on 11Apr2021, "tired" on 12Apr2021. Patient stated, "I am calling I had the Pfizer vaccine (Covid-19 Vaccine) on Saturday on April the 10th and everything was great probably about I would say about 45 minutes after I got the vaccine I felt chill and then the next day, on Sunday the 11th I had prompt pain and I had spotting (before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain for say). Actually I am a 57 years old woman and I have gone to menopause and my cycle has stopped. On Sunday I had body ache. Most of the day I took it easy and I slept but then next day tired beside that is the only kind of adverse reaction I had. It just trigger emergently it is it's good for everybody if you have any kind of symptoms or whatever you let you informed it's good to be informed. I got the vaccine on 10th got it on Saturday I had this spotting on 11th was sleepy on 11 and was tired on 12th too. And when I say spotting it is like it was having like cycle not, wasn't heavy it was spotting like bleeding it looks like bleeding." No treatment received for events. The outcome of the events was unknown. The event "it was spotting like bleeding it looks like bleeding" was considered as serious (medically significant). Schedule date of second vaccination was on 01May2021.
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| 57 | 2021-05-05 | loss of consciousness |
16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day...
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16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day later had an unexplainable seizure of two to three minutes and afterwards being unconscious for 25 minutes. Cat scan and MRI all normal.
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| 57 | 2021-05-06 | loss of consciousness, blood pressure increased |
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150...
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anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
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| 57 | 2021-05-07 | cerebrovascular accident |
Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good;...
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Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good; Had stroke like symptoms, but didn't have a stroke, had vertigo; Having a little bit of nausea and a little bit of weakness; Having a little bit of nausea and a little bit of weakness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:45 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as a single dose (at the age of 57 years) for covid-19 immunization. The patient's medical history included diabetic, high blood pressure (diagnosed with this 5 years or more ago, caller was not sure). The patient's concomitant medications were not reported. The patient was previously given flu shot (tries to stay up on taking flu shot. Tries to stay up on them as much as caller can, tries to get every year as long as didn't catch flu, as long as not some reason not to receive the shot), pneumonia shot in 2019 and arm was sore. The patient experienced getting severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke on 01Apr2021. It was further reported that patient got severe vertigo and it was like if she took her shot it was like 30 minutes after the shot. Patient was still having vertigo side effects. She went to the hospital, was in hospital from 02Apr2021 to 03Apr202 1and they diagnosed her with vertigo and they done tests and all her tests came back normal. Patient was trying to find out if she should I take the second Pfizer shot. It was also reported that later on that day patient called paramedics and was hospitalized for two days. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Wasn't sure if first dose Pfizer Covid Vaccine had anything to do with it, but could have dislodged something in caller's ear that led the vertigo on. Had to go see another specialist, eye ear, throat doctor and test came back fine with this doctor. The patient told the specialist she didn't feel comfortable just going to site where caller received first dose Pfizer Covid Vaccine, patient was more comfortable with hospital setting. The specialist told caller she probably needed to talk to someone that had something to do with the Pfizer Covid Vaccine. Caller was waiting on a call back from her Primary Care Doctor. Patient was supposed to have second dose Pfizer Covid Vaccine on 29Apr2021, next week, patient canceled the appointment due to trying to find out more information. iIt was mentioned that the patient was 75% back to the way usually feels. Having a little bit of nausea and a little bit of weakness. Patient does not have spinning of the room, dizzy and all of that like it was. Just doesn't feel too good. On an unknown date, the patient was having a little bit of nausea and a little bit of weakness. The patient was hospitalized for getting severe vertigo; diagnosed with vertigo, started to feel very ill and had stroke like symptoms, but didn't have a stroke, had vertigo from 02Apr2021 to 03Apr2021. The outcome of the events severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke was recovering and unknown outcome for the remaining events.
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| 57 | 2021-05-09 | heart rate increased | Swelling of site arm, increased heart rate, dizziness and weakness, hospitalization |
| 57 | 2021-05-11 | loss of consciousness |
Almost passing out; Very short of breath/Had trouble breathing; Coughing to the point of seeing blac...
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Almost passing out; Very short of breath/Had trouble breathing; Coughing to the point of seeing black; Could not walk from one room to the next with out being out of breath; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:30 (Batch/Lot Number: EW0170) as UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Medical history included asthma and sarcoidosis, drug hypersensitivity, allergies to cycline antibiotics. Concomitant medication included meloxicam (MELOXICAM) and omeprazole (PROTONIX [OMEPRAZOLE]). No Covid prior vaccination. Adverse event was reported as: Vaccine at 4:30 pm on Friday. Felt fine until later in the a.m. had trouble breathing. Very short of breath. Coughing to the point of seeing black and almost passing out. Could not walk from one room to the next without being out of breath. Adverse event start date: 24Apr2021, adverse event start time: 04:00 AM. Treatment received for events included nebulizer, rescue inhaler and Breo inhaler. The event outcome was recovering. No Covid tested post vaccination.
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| 58 | 2020-12-31 | palpitations |
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ...
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Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
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| 58 | 2021-01-03 | heart attack, heart rate increased |
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI;...
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12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
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| 58 | 2021-01-03 | chest discomfort, blood pressure increased |
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood ...
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15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.
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| 58 | 2021-01-03 | palpitations, chest pain, fast heart rate |
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain...
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30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-04 | heart rate increased |
Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a co...
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Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event. No follow up attempts are possible. No further information is expected.
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| 58 | 2021-01-04 | cardiac arrest, fainting |
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp...
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Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
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| 58 | 2021-01-04 | palpitations |
intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection...
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intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril. The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.
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| 58 | 2021-01-05 | fast heart rate, palpitations, blood pressure increased | Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing |
| 58 | 2021-01-06 | palpitations, heart rate increased |
Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. ...
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Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. I got help and Sat in office with nurse. My pulse was 140's ,I felt sweaty and shaky. Whole episode lasted approx 10 minutes
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| 58 | 2021-01-07 | heart rate increased |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-10 | fainting | Fatigue, muscle aches, mental fogginess, syncope, cold hands |
| 58 | 2021-01-10 | loss of consciousness |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | loss of consciousness |
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild...
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Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
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| 58 | 2021-01-11 | blood pressure increased |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-12 | body temperature decreased |
1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbin...
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1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbing joints. 2:00 PM temperature 101.8, took Acetaminophen, chills, headache, horrible pounding joint pain. 7:00 PM temperature 100.9, chills and exhaustion, took Acetaminophen . 1/13/21 4:00 AM, chills, temperature 100, took Acetaminophen. 9:00 AM exhaustion, massive body aches. 4:00 PM temperature 98.9, chills, exhausted. Have slept about 36-40 hours and lost 2 days of work.
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| 58 | 2021-01-12 | hypotension |
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat...
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Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
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| 58 | 2021-01-13 | palpitations |
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ...
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Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
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| 58 | 2021-01-13 | blood pressure increased |
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead...
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Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
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| 58 | 2021-01-14 | palpitations |
Pt stated that she felt her heart racing. She denied any other symptoms. She was walked over to the ...
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Pt stated that she felt her heart racing. She denied any other symptoms. She was walked over to the EMS area and placed on heart monitor and monitored for another 20 minutes.
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| 58 | 2021-01-15 | chest discomfort |
The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she...
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The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she sat down, she stated she had swollen fingers and hands, and felt chest tightness. She was then transported to the ED in a wheelchair.
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| 58 | 2021-01-17 | fainting |
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte...
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Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
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| 58 | 2021-01-18 | chest pain |
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,...
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Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
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| 58 | 2021-01-19 | heart attack, pulmonary embolism, deep vein blood clot |
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21...
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1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
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| 58 | 2021-01-19 | loss of consciousness |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | chest pain, chest discomfort | Mild pain & mild pressure on left side of chest |
| 58 | 2021-01-21 | blood pressure increased, body temperature decreased |
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v...
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Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
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| 58 | 2021-01-21 | heart rate increased |
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o...
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This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
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| 58 | 2021-01-21 | blood pressure increased | itching all over my face; elevated blood pressure; increased breathing rate |
| 58 | 2021-01-23 | troponin increased, chest pain, palpitations |
On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At ar...
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On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At around 2:30 on Jan 23 I had an argument with someone and felt my heart race for a minute and then chest pain radiating to my back. Went to the hospital at 7pm and was being ruled out for an MI.
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| 58 | 2021-01-24 | chest pain | Fatigue, nausea, diarrhea, chest pain |
| 58 | 2021-01-24 | nosebleed |
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fe...
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On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
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| 58 | 2021-01-25 | heart rate increased | Felt Lightheaded with fast Heart rate. |
| 58 | 2021-01-27 | chest discomfort |
About 5 hours later, I startd feeling like I was having flu symptoms; Late afternoon - 99.5 fever an...
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About 5 hours later, I startd feeling like I was having flu symptoms; Late afternoon - 99.5 fever and fatigue. By 8:00 p - fever was 100; joint and muscle aches and fatigue; Took Tylenol finally before bed - slept a little bit but woke up with 101 temperature and I took another Tylenol and went back to bed but couldn't sleep because of pain with muscles; sore throat and it went up to 101.4 - it would go down with Tylenol but it would shoot back up after 4 hours. Rollercoaster with that up through Sunday 10th - all day fever was over 101.4 - 101.6 with extreme fatigue; really bad muscle and joint pain; eat a little and pushed fluids. Didn't have to work Monday. Rested and I felt a little tight in my chest and took Albuterol. Monday morning temp was 101; but started going down to 99 range fever; I had a previously schedule visit with my dr. and it ended up being a sick visit. He said to keep an eye on it. He told me not to go to work on Tuesday or Wednesday. Things were getting better but still had sore throat; shortness of breath and muscle aches/joint pain but lower temp. Wednesday night I called out from work because things got worse with my breathing/chest got tight etc but not fever anymore Had a virtual Urgent care visit - for the COVID test. COVID test on Thursday. Went to back to work - and I still have a slight bit of joint pain.
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| 58 | 2021-01-27 | palpitations |
It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (vi...
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It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
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| 58 | 2021-01-28 | heart rate increased |
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat...
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Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
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| 58 | 2021-01-28 | very slow heart rate, hypertension | Left sided weakness, headache, chills, hypertension (normally hypotensive), bradycardia. |
| 58 | 2021-01-29 | fainting |
15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxiou...
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15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxious appearing. Patient taken to the Emergency Room for further evaluation. Upon presentation to the ER, patient diagnosed with vasovagal syncope, treated with fluids and zofran and discharged home.
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| 58 | 2021-01-30 | cardiac arrest |
After being observed for approximately 20 minutes and patient walked to her car without assistance I...
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After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
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| 58 | 2021-01-31 | fast heart rate |
Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalize...
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Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalized body aches
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| 58 | 2021-01-31 | low blood platelet count, platelet count decreased |
Idiopathic thrombocytopenia Onset Jan 27; platelets dropped to <3000. Good response to decadron wi...
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Idiopathic thrombocytopenia Onset Jan 27; platelets dropped to <3000. Good response to decadron with rise to 100,000 by feb 1. No significant bleeding
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| 58 | 2021-01-31 | chest discomfort |
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic...
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Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
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| 58 | 2021-01-31 | chest pain | Metalic taste in throat Burning in chest lips swelling tongue swelling with swallow difficulty |
| 58 | 2021-01-31 | palpitations |
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio...
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Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
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| 58 | 2021-01-31 | chest discomfort |
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E...
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chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
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| 58 | 2021-02-01 | cardio-respiratory arrest |
Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfa...
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Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.
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| 58 | 2021-02-01 | chest pain |
felt a strong pain in the chest; injection site was color purple; injection site was color red, swol...
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felt a strong pain in the chest; injection site was color purple; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 14Jan2021 to 14Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that 2 days after the administration, the injection site was color red, swollen and with pain; 3 days after the administration the injection site was color purple; and 4 days after the administration she felt a strong pain in the chest. The outcome of the events was unknown. Information on lot/batch has been requested.
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| 58 | 2021-02-02 | blood pressure increased |
About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat ...
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About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat for a while to see if it would go down being monitored by 2 NPs in the office. The BP remained elevated for a while and after about 2hrs it came down. I developed a headache that got more profound over time but the dizziness and feeling of being hot left and about 5hrs the headach left and I felt better. Went to work the next day feeling a little better but got a massive headache so I took some advil and after about 4hrs it finally let up. The next day I got a slight headache but it left after about an hour and hasnt had anymore symptoms since.
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| 58 | 2021-02-02 | fainting |
Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vacci...
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Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vaccines/venipuncture in past. Epi-pen given prior to obtaining vasovagal syncope hx. Patient awoke and symptoms improved.
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| 58 | 2021-02-03 | chest discomfort |
Fever 101.9 at 18 hours, body aches, headaches, chills, tight chest/throat post 48 hours. Fevers an...
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Fever 101.9 at 18 hours, body aches, headaches, chills, tight chest/throat post 48 hours. Fevers and chills back at 48 hours with headaches again.
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| 58 | 2021-02-03 | blood pressure increased |
patient felt lightheaded within 5 minutes of arriving in observation areas. Vitals upon initial symp...
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patient felt lightheaded within 5 minutes of arriving in observation areas. Vitals upon initial symptom reporting BP 158/101, HR 66, O2 sat 97%, temperature 36.9. Patient reported not eating anything this morning prior to arrival at vaccination site. Water, crackers provided. Feet elevated for 30 min and ice packs provided. Vitals 30 min later noted BP 170/78, HR 60, O2 sat 99%. Patient transported to ED via wheelchair with RN for further monitoring.
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| 58 | 2021-02-03 | fainting | synopcal event |
| 58 | 2021-02-04 | fainting |
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita...
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Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
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| 58 | 2021-02-04 | heart rate increased, hypertension |
Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and h...
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Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and heart rate
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| 58 | 2021-02-08 | palpitations, fast heart rate, atrial fibrillation |
Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a c...
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Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a contactable healthcare professional (HCP). This HCP reported similar events for 2 patients. This is 1st of two reports. This 58-year-old female HCP (patient) reported for herself that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) on 10Jan2021 at 0.3 mL single by intramuscular injection left arm for COVID-19 vaccination. Medical history included ongoing hypertension and diabetes type 2, both diagnosed about 10 years ago (2011). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EH9899) on 21Dec2020 at single dose for COVID-19 immunisation. The patient reported that a few days after receiving the 2nd dose (on 14Jan2021), she went into atrial fibrillation and had been having palpitations ever since. She had a cardiology appointment in a few weeks and they started her on apixaban (ELIQUIS). Lab data on 14Jan2021 included EKG: normal sinus and Kardiamobile (a medical grade ECG): it showed tachycardia and at least one other time showed atrial fibrillation, heart rate 141. The outcome of palpitations was not recovered, outcome of other events was unknown. Reporter seriousness for atrial fibrillation and palpitations was medically significant.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of atrial fibrillation cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021111803 same reporter/drug, similar events, different patient
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| 58 | 2021-02-10 | nosebleed, blood clot |
Dose #2 - Nose bleeds following the 2nd Pfizer COVID-19 vaccine beginning a few days later and lasti...
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Dose #2 - Nose bleeds following the 2nd Pfizer COVID-19 vaccine beginning a few days later and lasting at least (1) one week; on 2/2/2021 this patient coughed up a pea-sized bright red blood clot; no blood clots noted since that one time and no petechiae noted; severe body and joint aches and pain beginning the next day and lasting 24 hours. No fever noted on any day. Dose #1 - Nausea / diarrhea beginning a few days later and lasting two and one-half (2 1/2) weeks; sore arm same day and lasting at least 3 days. No fever noted on any day.
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| 58 | 2021-02-10 | haemoglobin decreased |
Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid. Exploratory laparotomy ...
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Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid. Exploratory laparotomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy completed within 12 hours of presenting symptoms
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| 58 | 2021-02-14 | loss of consciousness |
Had feeling of eurphoria. Then not feeling well at 1545. Then passed out at 1930, fever, chills, and...
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Had feeling of eurphoria. Then not feeling well at 1545. Then passed out at 1930, fever, chills, and general malaise began. Worsened on 1/12/2021. Had fever 102 F. Had rigors even with Acetaminophen and Ibuprofen. Then develp. resp. issues, using advair/albuterol/singulair.
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| 58 | 2021-02-15 | fainting, blood pressure increased |
I fainted almost immediately but I was extremely anxious and crying/hyperventilating. I also had nau...
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I fainted almost immediately but I was extremely anxious and crying/hyperventilating. I also had nausea and retching, My blood pressure went up. A couple of hours later I had a sever head ache, chills and sweats with body aches that lasted through the next morning.
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| 58 | 2021-02-15 | palpitations, blood pressure increased |
Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue...
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Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue. About 5 minutes after that, I had a metallic taste in my mouth. I was monitored and my blood pressure was elevated. My pulse was normal. They monitored me for 1 hour and then let me go home. The tingling continued through the night. Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue. Two days after the vaccine, my heart began to race. My blood pressure remained high for approx. 2 1/2 weeks. My heart beat continues to race at times. I followed up with my PCP and cardiologist who both took EKGs which were normal.
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| 58 | 2021-02-17 | cerebrovascular accident | admitted to hospital for a stroke |
| 58 | 2021-02-19 | fast heart rate |
Tachycardia that started about 40 minutes after vaccine that lasted for 8.5 hrs Consulted with my ...
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Tachycardia that started about 40 minutes after vaccine that lasted for 8.5 hrs Consulted with my primary card doctor . EKG was done . Treated by hydrating and resting in bed Resolved after about 81/2 hrs
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| 58 | 2021-02-21 | heart rate increased |
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ...
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The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
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| 58 | 2021-02-22 | chest discomfort |
Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She repo...
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Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She reports that about 2:15pm while she was on her way home, she developed some chest fullness/tightness and some mild SOB. She returned to Vaccine clinic for evaluation. She was able to park and walk-in unassisted. Denies throat itching/swelling No rash Vitals: Initial set 115/66, HR 70, RR 18, O2 sat 99% Continuous pulse oximetry with oxygen sats 99-100% and HR 70-75. Â Gen: WDWN WF NAD, conversing easily without dyspnea. CV: RRR no MGR Resp: CTA bilaterally, no increased WOB Skin: warm, dry, not diaphoretic, no rash Neuro: afocal,MAE Â Fingerstick glucose: 89 Â Monitored x 15 minutes with significant improvement and resolution of chest discomfort and SOB Discussed with medical director and transferred to employee health for additional 30 minutes of monitoring. Monitored x 30 minutes in SEH. Complete resolution of symptoms. Vitals q 15 minutes x 2 @1513 133/69 HR 71 @ 121/65 HR 72 Cleared to return home. Discussed signs necessitating emergent treatment including chest pain, SOB, throat swelling/itching.
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| 58 | 2021-02-23 | fainting | Fainted twice on the sidewalk within an hour and a half of shot. Ambulance was called. |
| 58 | 2021-02-23 | deep vein blood clot, pulmonary embolism |
Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021...
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Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021.
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| 58 | 2021-02-25 | chest pain |
After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, ...
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After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, feeling hot/cold alternating, arm pain, muscle aches. Day 3-5, employee became more sick with mild intermittent chest pains, extreme exhaustion, muscle aches and spasms, dizziness, headaches, feeling hot and cold alternating, but no fevers noted. Day 7, employee started to feel better, but symptoms continued with fatigue which persisted for a several days until she was back to baseline
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| 58 | 2021-02-28 | fainting | Dizziness, sweating, flushed followed by Syncopal episode, EMS called |
| 58 | 2021-03-01 | blood clot |
Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient hers...
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Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered. Information about lot/batch number has been requested.
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| 58 | 2021-03-02 | blood pressure increased |
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ...
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High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
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| 58 | 2021-03-02 | chest discomfort |
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac...
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Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
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| 58 | 2021-03-02 | hypotension, fainting |
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotens...
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Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
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| 58 | 2021-03-03 | oxygen saturation decreased |
After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed wi...
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After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed with COVID via POCT on 2/25/21 and was discharged from ED given lack of symptoms. Returned 2/27/21 after oxygen saturation found to be ~50% at home. Admitted for severe COVID infection requiring dexamethasone and remains inpatient.
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| 58 | 2021-03-03 | chest pain |
between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble ...
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between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight
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| 58 | 2021-03-04 | palpitations |
Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleep...
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Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleeping with blankets and a space heater
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| 58 | 2021-03-04 | chest pain |
Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard t...
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Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard to swallow, hard to breath. Taken to ER via ambulance.
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| 58 | 2021-03-05 | heart rate increased |
Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, ...
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Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, difficulty focusing eyes. Aches started at 6:30 am. High heart rate noted at 10:00 am. The rest came on in the afternoon. Took my vitals when I got home from work (7 pm). Chills, cold extremities through the night. By 5am, temp down to 100. By noon next day, BP and HR normal. Dizziness still comes and goes.
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| 58 | 2021-03-06 | chest discomfort |
Patient experienced chest tightness and itching/splotching on right forearm. She was given 50 mg of...
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Patient experienced chest tightness and itching/splotching on right forearm. She was given 50 mg of oral liquid diphenhydramine.
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| 58 | 2021-03-07 | lightheadedness, chest discomfort, chest pain |
During the post-vaccination observation period, vaccine recipient complained of vertigo and some mid...
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During the post-vaccination observation period, vaccine recipient complained of vertigo and some mid-sternal chest pain. They were seen by EMS and the cardiac monitor showed abnormal rhythm. They were transported to emergency department Medical Center. They reported chest pressure and near syncope. During reexamination, there was no chest pain or palpitations. They were discharged to home. Registered 03/05/2021 11:37 AM, Discharged 03/05/2021 4:38 PM.
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| 58 | 2021-03-07 | chest discomfort |
EMS POST VACCINE ADMINSTRATION PATIENT C/O CHEST TIGHTNESS AND NEW ONSET OF NONE PRODUCTIVE COUGH. ...
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EMS POST VACCINE ADMINSTRATION PATIENT C/O CHEST TIGHTNESS AND NEW ONSET OF NONE PRODUCTIVE COUGH. EMS ASSESED NEED TO CONTACT AMBULANCE. PATIENT REFUSED TRANSPORT TO ANY MEDICAL FACILITY. PATIENT STATED SHE WOULD GO TO THE HOSPITAL ON HER ON IF NEEDED. STATES SHE HAS A HISTORY OF R DIAPHRAM PARALYSIS. VITAL SIGHS AT 1320 PULSE 92, RESP 20 B/P 112/69. OXYGEN SAT 98% ON 2/L ON PERSONAL HOME OXYGEN. A & O X 4. PATIENT LEFT AMA AT 1326. RN CALLED PATIENT 3/8/2021 @ 8:06 PM. NO ANSWER AND NO VOCIE MAIL AVAILABLE TO LEAVE MESSATE.
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| 58 | 2021-03-07 | chest discomfort |
Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever ...
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Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever (100), chills, all over body aches, sore throat, alteration of taste, heaviness in chest, nausea. The headache lasted a few days .... each morning for the next 4 days I awaoke with headaches
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| 58 | 2021-03-08 | palpitations |
She noted at 1515 sweating, feeling like heart racing and felt like throat closing . Required 2 dose...
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She noted at 1515 sweating, feeling like heart racing and felt like throat closing . Required 2 doses of 25 Mg liquid benadryl and 60 Mg Dexamethasone which then she noticed her throat not feeling so tight. Walked out and was given a prednasone burst for home 40 mg, 40 mg, 20 mg, 20 mg, 10 mg 10 mg.
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| 58 | 2021-03-08 | palpitations |
patient complained of racy heart rate and feeling unwell. She complained that she was tired and ligh...
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patient complained of racy heart rate and feeling unwell. She complained that she was tired and lightheaded. patient did state she took 2 benadryls and anti-anxiety medications prior to vaccination per drs orders. I took her blood pressure--first reading was 120/99 and HR was 88bpm-- 2nd reading was 112/82 HR unknown-- and third reading blood pressure was 128/32 HR 163 and fourth reading was. 134/90 and hr 91. Patient stated she hadnt eaten all day--gave her cookies and water. Patient stated she was starting to feel better-counseled her on what to do if her symptoms come back and/or get worse. Walked her to the door with her husband.
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| 58 | 2021-03-09 | loss of consciousness |
A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got ...
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A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got hot and felt like she was going to pass out. Patient did pass out while sitting in chair. She came back alert and felt much better. THe patient stayed in the lobby for a bit until she felt ok
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| 58 | 2021-03-09 | palpitations |
Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous rep...
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Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: 013L20A) via an unspecified route of administration on 05Feb2021 08:45 in left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient had heart palpitations after vaccine - only lasting a few seconds, sore injection site and body aches in the back - both of which were relieved with naproxen sodium (ALEVE), small headache - went away shortly after getting out of bed. Event onset date reported as 05Feb2021 12:30. Treatment received for the events. The outcome of the event heart palpitations was recovered on 05Feb2021, of other remain events was recovered in Feb2021.
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| 58 | 2021-03-09 | hypertension, heart rate increased | Stabbing pain in back increased heart rate leading to high blood pressure readings |
| 58 | 2021-03-09 | fainting | Syncopal episode |
| 58 | 2021-03-10 | chest discomfort |
1705 Complaint of tightness in chest. No rash or swelling of tongue or lips. Patient took Benadryl...
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1705 Complaint of tightness in chest. No rash or swelling of tongue or lips. Patient took Benadryl and used their inhaler. BP: 162/96 O2: 97% P: 77 R: 20 1735 Patient states chest tightness is resolving. 150/82 O2: 97% R: 20
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| 58 | 2021-03-10 | palpitations |
Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started abou...
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Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started about 35 minutes after shot Directly after shot I felt a rush of blood and felt uneasy. They watched me for about 20 minutes but the severe symptoms started about 35 minutes after shot
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| 58 | 2021-03-10 | chest discomfort |
beginning approximately 28 hours after vaccination, patient developed dry, hacking cough, tightness ...
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beginning approximately 28 hours after vaccination, patient developed dry, hacking cough, tightness in chest, shortness of breath/dyspnea and wheezing with exertion. Coughing, and chest tightness/wheezing exacerbated by laughing, deep breaths and exertion. Symptoms limited patient from exercising and continued until 6 days after symptoms started. Day 8 after vaccination, symptoms resolved. Patient able to resume routine exercising without cough and feelings of shortness of breath/dyspnea.
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| 58 | 2021-03-12 | chest pain |
Four days after I developed pain in my chest. Intermittent pain which has required several visits to...
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Four days after I developed pain in my chest. Intermittent pain which has required several visits to primary care physician, urgent care, ER, Cardiologist and GI physician. Current diagnosis Prinzmetal angina
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| 58 | 2021-03-12 | lightheadedness | vasovagal response, monitored, cool packs, sx resolved |
| 58 | 2021-03-13 | heart rate increased |
Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, naus...
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Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light. By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking. Symptoms lasted 3 days. On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
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| 58 | 2021-03-17 | chest pain |
Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching ...
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Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching all over, as well as a sore throat. She did not go to the ER. She treated symptoms with Tylenol. Symptoms were intermittent and lasted 2 weeks
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| 58 | 2021-03-17 | chest discomfort |
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like...
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extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
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| 58 | 2021-03-17 | pulmonary embolism, chest pain |
patient developed dyspnea and pleuritic chest pain 4 days after 2nd dose. improved on steroids then...
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patient developed dyspnea and pleuritic chest pain 4 days after 2nd dose. improved on steroids then worsened after steroid completion. diagnosed with P.E. (Pulmonary Embolism) today in ED visit. patient is a physician
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| 58 | 2021-03-18 | blood pressure increased |
Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, ch...
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Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, chills, headache, sweats. Early afternoon in the car I had trouble breathing, cold sweats, chills, coughing trying to breathe. My husband went immediately to the pharmacy to purchase Benadryl and opened the capsules and poured in my mouth along with water as my body became completely limp. At home my husband helped me get to bed and gave me 2 rapid release Tylenol tablets. Day 3. 3/12/2021- In the morning, I felt better until I had a cup of coffee and the chills, sweats, nausea, vomiting and blood pressure started escalating 135/98. I had no previous concerns with blood pressure before the vaccine. I had difficulty speaking (stuttering, confusion and brain fog. I was still so so tired. Day 4, 3/13/2020 - Unable to remain awake after having a sip of water. Blood pressure 150/101 and ate 3 nuggets and body became limp again and unable to walk and husband carried me to bed. (Difficulty speaking and repeating words over and over-confusion). Day 5, 3/14/2020- In the morning, I felt better and my husband gave me a blood pressure pill (Triamterene/Hctz) . I slept most of the day and had no water, no food. I was extremely exhausted and ate in the evening. I had chills, sweats, headache and my body became limp again and husband carried me to bed. Day 6. 3/15/2020- In the morning called Dr. for tele-visit and gave her details of what was happening. I had no food or water and still felt tired. I went to office for lab work around 4:30. I was walking, but extremely exhausted and speech difficulty. Day 7. 3/16/2021 -. In the morning blood pressure was 139/96 - took another blood pressure tablet and had a smoothie and felt much better only chills, no headache. Blood test were normal, and I ate dinner and then chills, sweats, headache and husband helped me walk to bed. After about 30 minutes, legs were movable, but upper body was numb for an additional 30 minutes and then everything seemed fine. I got up and walk around and went back to bed later in the evening. Day 8. 3/17/2021-First day no meds at all, no BP meds, no Tylenol and I was feeling so much better. I ate throughout the day with few symptoms except stuttering and repeating words when speaking. Day 9. 3/18/2021- I spoke with Dr. for appointment on the 19th. I felt stronger and ate breakfast, Lunch and dinner and was feeling normal except for occasional stuttering in speech. Day 10 3/19/2021 - No food in the morning, I visited Dr. at 8:35 for examination and she sent me for ct-scan. Blood pressure was back to normal 122/82 with no meds. I felt fine and later today received normal results from CT-scan. I am hopeful that in the coming days, my speech will completely back to normal.
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| 58 | 2021-03-18 | atrial fibrillation |
night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night ...
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night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.
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| 58 | 2021-03-19 | fainting |
She had received her first Covid vaccination this afternoon and following that she became dizzy and ...
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She had received her first Covid vaccination this afternoon and following that she became dizzy and had a syncope spell. She tells me that with previous vaccinations this has routinely happened and so it is not different. She was not aware of her surroundings for about 2 minutes after this happened although there was no witnessed jerking or seizure movement. At this point she feels about 90 to 95% back to normal and denies any pain anywhere including in her chest. Initially she had some tingling in her arms although that has resolved.
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| 58 | 2021-03-19 | chest discomfort |
Shot at 2 pm, immediate pain in left side of neck and headache on left side of head. 4 pm got hives....
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Shot at 2 pm, immediate pain in left side of neck and headache on left side of head. 4 pm got hives. 7 pm chest tightness. 8 pm trouble breathing, so went to ER. Had an EKG and other heart related tests. Had blood work and chest xray. Gave Benadryl. Had taken Pepcid at 4 pm
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| 58 | 2021-03-21 | chest discomfort, blood glucose increased, hypertension |
Dizziness, hypertension 210/120, chest tightness, normal HR. Treatment: 0.1mg Clonidine tablet x2PO....
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Dizziness, hypertension 210/120, chest tightness, normal HR. Treatment: 0.1mg Clonidine tablet x2PO. Improved sypmtoms, BP was stable at 160/69.
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| 58 | 2021-03-21 | blood pressure increased | nausea, diarrhea, headache, fatigue, increased blood pressure, dizziness |
| 58 | 2021-03-22 | fainting |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-03-22 | hypotension, pallor |
patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 9...
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patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 911 and EMT came checked vitals her blood pressure was low and they took her by ambulance to hospital
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| 58 | 2021-03-23 | chest pain |
After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/...
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After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10. First response called and patient taken to ER for further monitoring.
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| 58 | 2021-03-23 | blood pressure increased | Blood pressure is up 129/98 |
| 58 | 2021-03-23 | chest pain |
Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when ting...
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Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when tingling , then I felt it run across my chest and my heart or lungs physically hurt then it went to my head and from the moment on if I turned my head in any direction left or right I would be very dizzy. I could keep my head and vision straight ahead and only felt a distance and had to concentrate very hard .
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| 58 | 2021-03-24 | palpitations |
58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfiz...
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58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfizer vaccine yesterday. Today awoke feeling funny, felt some tightness in throat, trouble swallowing, more sob, palpitations, headache. When she arrived at work this morning, started dry heaving very nauseated and had to go home. Driving home, she saw her face and noticed it was swollen. No prior hx of allergic reactions. No other new meds or foods in that time. No chest pain. 58F with likely allergic reaction anaphlyaxis to pfizer vaccine. No severe facial swelling, tongue swelling, wheezing but symptomatically concerning given throat tightness, subjective facial swelling (I did see some mild periorbital edema but unable to observe other differences but she could). Not on any ace inhibitor. Less likely chf, acs, pna/ ptx, asthma Pt symptomatically improved a lot after epi, benadryl Observed and deemed stable Dc with prednisone and pepcid
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| 58 | 2021-03-25 | chest discomfort |
58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from do...
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58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from doxycycline), seasonal allergy, mild intermittent seasonal asthma developed facial angioedema, erythematous, non-pruritic macules on her face/chest, and a "tiny bit" of chest tightness 5 hours after Pfizer vaccine. Responded to benadryl. 24 hours later facial swelling returned. On 3rd day after vaccination, swelling had fully resolved. No history of dermal fillers. No history of miralax use. Has tolerated influenza vaccine. No recent other vaccines. Skin testing to miralax, methylprednisolone and triamcinolone was negative. I advised her to avoid second dose of Pfizer vaccine.
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| 58 | 2021-03-25 | palpitations |
Client began having palpitations after receiving the vaccine. Fire Rescue evaluated the patient on s...
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Client began having palpitations after receiving the vaccine. Fire Rescue evaluated the patient on site. Patient released to go home at 11:03 am. Per Fire Rescue no additional evaluation needed.
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| 58 | 2021-03-25 | chest discomfort |
On Wednesday morning I had slightly raised skin in the small of my back and itching. This went away ...
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On Wednesday morning I had slightly raised skin in the small of my back and itching. This went away in a day. However, i continue to get raised spots on my chest that sre moderately itchy. I also had a spot on my right jaw that got itchy but no raised skin...i think right over a lymph node mid-jaw on right.
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| 58 | 2021-03-27 | palpitations |
Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st ...
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Headache, 101 fever, dizzy, chills, heart race, jaws hurt, fatigue, sore throat, cough. This is 1st day.
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| 58 | 2021-03-28 | fainting |
Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and chee...
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Patient is spanish speaker only, 10 minutes post vaccination, lower lip became numb, eyelid and cheeks were swollen, syncope, dysphagia occurred. As of today, only has numbness in lower lip. Recommended for her to see provider right away. Patient says she does not have insurance. Recommended some income based clinics but call was disconnected, called back but no answer.
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| 58 | 2021-03-28 | platelet count decreased |
She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 devel...
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She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 developed severe headache and came to the Medical Center ER. She had a large intracranial hemorrhage. Platelet count was 4,000. She had a normal platelet count in December 2020. She had not received chemotherapy for her breast cancer, only radiation. The hemorrhage rapidly expanded. She was intubated and admitted to the ICU under my care. Her husband opted for palliative extubation and she died soon after.
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| 58 | 2021-03-30 | blood pressure increased |
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ...
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Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
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| 58 | 2021-03-30 | chest discomfort, troponin increased, inflammation of the heart muscle |
Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after gett...
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Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after getting up at 6 am 3/29/2021. Slight light-headedness was felt shortly afterwards. Symptoms did not change after moving around & on the advice of patient's insurance company's Nurse Line, she went to the Emergency Room shortly after 7 am. Patient underwent a heart catheterization that day (3/29/2021) and a cardiac MRI the following day (3/30/2021). Cardiologist informed patient he suspected either Stress Cardiomyopathy or Myocarditis. Patient was discharged 3/31/2021 with 4 medications and follow-up appointments scheduled
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| 58 | 2021-03-30 | heart rate increased, palpitations |
allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while dri...
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allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while driving home, somehow missed her exit; face is swollen; fast heartbeat; heart racing really fast; This is a spontaneous repot from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), intramuscular in the muscle of upper left arm (deltoid left) on 03Mar2021 17:15 at a single dose for COVID-19 immunization. The vaccine was administered at a pharmacy, not a facility. No other vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history included hormone replacement therapy, high blood pressure, and "very sick she guessed from a cold and had asthma" on 2011 (from 10 years prior to the report; this was the only time she had asthma, and her physician said her asthma can come on because of being sick). The patient stated that she generally has higher blood pressure than she would like, but she is otherwise very healthy, and never had an allergic reaction to anything. Family history relevant to the adverse events was none. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) for high blood pressure, valacyclovir (VALACYCLOVIR), rosuvastatin (ROSUVASTATIN), omega-3 nos (OMEGA-3 NOS, capsule), estrogen (ESTROGEN) for Hormone replacement therapy, progesterone (PROGESTERONE, 100 mg capsule) for Hormone replacement therapy, all were from unspecified date and ongoing. It was reported that patient gets her flu shot every year and never had an adverse reaction. The patient reported that she had an allergic reaction to the first dose of PFIZER-BIONTECH COVID-19 VACCINE she received last Wednesday (03Mar2021) after an hour after she received it (18:45) while driving. She mentioned that she saw on the package insert what a severe allergic reaction would include. She experienced swelling of the face and a fast heartbeat but no difficulty of breathing on 03Mar2021. The patient further explained that she had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 03Mar2021 around 17:15 at a pharmacy. She left the pharmacy around 17:30. While she was driving home, she started to feel her heart racing really fast and felt like her throat was constricting within about 30 minutes of being administered the vaccine, by around 17:45. She was very flustered while driving home which is usually about 30 minute drive; but somehow she missed her exit and it was rush hour so it was about 18:15 when she got home. When she got home her husband asked her if she had been crying because he said her face looked weird. She told him he thinks her face is swollen. All of these events lasted maybe 1-2 more hours or less after she got home around 18:15, maybe a few hours before she recovered completely. She was expecting soreness and pain from the PFIZER-BIONTECH COVID-19 VACCINE but was not expecting the fast heartrate or swelling. She was reading through the information she got from the pharmacy for the PFIZER-BIONTECH COVID-19 VACCINE because she was a little concerned about getting the second dose due to these events. She has never had an allergic reaction to anything before and wondered if she should go to a hospital for her second dose of the PFIZER-BIONTECH COVID-19 VACCINE in case she has these events again, or a worse reaction. She asked about these events and dosing recommendations for the Pfizer. The reported adverse events did not require a visit to the emergency room or physician office. The patient was not hospitalized. Outcome of the events was recovered on 03Mar2021.
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| 58 | 2021-03-30 | pulmonary embolism |
bilateral pulmonary emboli; This is a spontaneous report from a contactable Physician. A 58-year-old...
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bilateral pulmonary emboli; This is a spontaneous report from a contactable Physician. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration Date: unknown) via intramuscular in the left arm on 05Mar2021 10:15 AM at single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis and asthma. Patient had no known allergies. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration Date: unknown) on 12Feb2021 for COVID-19 immunization. On 09Mar2021 17:00 (5.00 PM), the patient experienced bilateral pulmonary emboli, which resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received blood thinners as treatment for the event. The outcome of the event was not recovered. Information on the lot/batch number has been requested. ; Sender's Comments: Based on current information available, the event bilateral pulmonary emboli mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent treatments are missing for a medically meaningful assessment.
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| 58 | 2021-04-01 | hypotension |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 58 | 2021-04-04 | chest pain, troponin increased |
4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospita...
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4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospital ED at 4:30am. First EKG negative for changes. First tryponin lab 0 and negative. Approximately noon, 2nd tryponin elevated at 0.54. Right radial access heart catheterization at approximately 1pm shows small branch of LAD with SCAD. Medical management with IV heparin, Plavix, and daily baby ASA 81mg. Discharged to home 4/4/21.
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| 58 | 2021-04-09 | loss of consciousness |
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming....
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developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-04-12 | pulmonary embolism | Second vaccine received on 4/6/21. Pulmonary Embolism on 4/11/21. Death on 4/13/21. |
| 58 | 2021-04-14 | anaemia |
K92.1 - Gastrointestinal hemorrhage with melena E87.6 - Hypokalemia D64.9 - Symptomatic anemia R10.3...
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K92.1 - Gastrointestinal hemorrhage with melena E87.6 - Hypokalemia D64.9 - Symptomatic anemia R10.32 - Left lower quadrant abdominal pain
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| 58 | 2021-04-14 | heart attack |
K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type R06.02 - Shortness...
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K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type R06.02 - Shortness of breath N18.6 - End stage renal disease E87.5 - Hyperkalemia D50.0 - Blood loss anemia J81.1 - Pulmonary edema I21.4 - NSTEMI (non-ST elevated myocardial infarction)
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| 58 | 2021-04-18 | oxygen saturation decreased |
Vaccine #1 at 9:45am on 3/30/21: Started feeling tired in first 12 hours; next 12 hours nausea, diar...
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Vaccine #1 at 9:45am on 3/30/21: Started feeling tired in first 12 hours; next 12 hours nausea, diarrhea, aches, fever 2.5-3 degrees elevated; next nine hours same with increasing intensity along with trouble breathing. Went to ER at 5:30pm on 3/31/21. Blood oxygen was at 72%. Rapid covid test negative. Chest X-ray described as ?white cracked glass?; 2nd covid test negative. Admitted as non-covid patient at 11:30pm. On BiPAP machine at 100% oxygen for for two days. In hospital for nine days.
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| 58 | 2021-04-18 | oxygen saturation decreased |
Vaccine #1 taken at 9:45am; first 12 hours tiredness; next 12 hours nausea, diarrea, fever (elevated...
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Vaccine #1 taken at 9:45am; first 12 hours tiredness; next 12 hours nausea, diarrea, fever (elevated 2.5-3 degrees from normal); body aches; difficulty breathing; next 9 hours body aches, fever and difficulty breathing intensified; went to ER at 5:30pm; blood oxygen at 72%; Rapid Covid test negative; chest xray presented as "white cracked glass"; 2nd covid test negative; admitted to hospital at 11:30pm as non-covid patient; on BiPAP machine at 100% oxygen for next 36 hours; weaning off oxygen over nine days in hospital; small blood clot in lungs found via CT Scan; treated with IV broad spectrum antibiotics and steriods; Section 21: Ascension ; 9-day hospital stay;
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| 58 | 2021-04-21 | blood pressure increased |
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve...
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inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
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| 58 | 2021-04-24 | chest pain |
Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professi...
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Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 08:00 (Lot Number: EM9810) at the age of 58-year-old as single dose for covid-19 immunisation. Medical history included ongoing High BP that was under control with medication from 2016, ongoing low Thyroid from 2017, Low Potassium 3.1 on 06Feb2021. The patient's concomitant medication was none. The patient previously received the first dose of BNT162B2 on 18Jan2021 11:45 am (lot number: EL3247) with Anatomical Site of injection: Left at the age of 58 years old for covid-19 immunisation and experienced Chest Pain on 22Jan2021 15:00 which required visit to Physician Office, Chest Pain 06Feb2021 (Several days) which required visit to Emergency Room. Vaccination facility type was hospital. No Prior Vaccinations. The patient experienced chest pain on 26Feb2021. The event required visit to Emergency Room. Event Outcome reported as "Prinzmetal Angina". Relevant Tests includes: Covid-19 on 23Dec2020 with Result: (-); Covid-19 on 18Jan2021 with Result: (-); Covid-19 on 21Jan2021 with Result: (-); X- Ray Chest on 06Feb2021 with Result: (-); EKG on 06Feb2021 with Result: (-); Low Potassium on 06Feb2021 with Result: 3.1. The outcome of the events was unknown.
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| 58 | 2021-04-24 | lightheadedness |
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my...
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She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
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| 58 | 2021-04-28 | ischemic chest pain |
a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm ...
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a big jolt immediately following in my heart/My heart feels sore off and on; shot was put in my arm with some force and I felt a jolt in my arm; fatigue; body aches; coughing; headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 15:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, exercise-induced asthma and penicillin allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), estradiol and progesterone, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 in the left arm on 23Mar2021 04:00 PM (at 58 years of age) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. The patient had no covid prior vaccination. She has not been tested for Covid post vaccination. The patient reported that the shot was put in the arm with some force and she felt a jolt in her arm and a big jolt immediately following in her heart. She mentioned that her heart felt sore off and on in that spot the following day 14Apr2021. No other unusual symptoms just the expected ones including fatigue, body aches and some coughing and headache. The events started on 13Apr2021 15:30 with outcome of recovering. The patient did not receive any treatment for the events. Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information, and on a plausible temporal association, the Company considered that a reasonable possibility could not be completely excluded that the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to the occurrence of the reported event Big jolt immediately following in my heart. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-04-29 | loss of consciousness |
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ...
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This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
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| 58 | 2021-04-30 | heart rate increased, atrial fibrillation |
A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and ...
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A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter/Fast heart beat; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter; Extreme tiredness; Bad headache; Fever of 99.4, 99.7, and 100.8; Chills; feeling yucky; Body aches; Feeling unwell; sick all day the day after but was fine by Sunday; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 09Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy on the bottom of her feet, cancer and cannot sleep from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate at 275 mg, daily (125mg of metoprolol succinate in the morning and 150mg of metoprolol succinate in the evening) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Mar2021 at 10:00AM (at the age of 58-years-old) in left upper arm for COVID-19 immunisation. The patient received her 2nd dose of the Pfizer COVID Vaccine on 09Apr2021. She was sick all day the day after (10Apr2021) but was fine by Sunday. On Monday, 12Apr2021, she mentioned that she underwent radiation therapy, then noticed that her injection site was swollen, red, and warm to the touch on 13Apr2021. On 10Aapr2021, her heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter. She mentioned that the COVID shot made it go up. She is asking how long these side effects should last and for what to do. She mentioned that the nurse at her doctor's office told her to contact Pfizer on what to do. She is a high-risk cancer patient. She received her second dose of the COVID vaccine on 09Apr2021. The next day, she experienced tiredness, a headache, chills, and body aches. She also had a fever of 99.4, 99.7, and 100.8. She was feeling unwell. Then she got a fast heartbeat. She has been having that problem. She has A-Fib and A-Flutter. She has been doctoring every week about her A-Fib and A-Flutter. Then she was fine. On Monday, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red and hurting. Then her heartbeat started back beating fast. She has had a headache on and off. She had a headache on Monday, Tuesday and Wednesday. She does not look at her weight. She has gained so much weight since cancer. She retains liquids because of her cancer. She is probably about 230 pounds. She has been tired because of her cancer. But this was different, this was extreme tiredness. Began on Saturday, 10Apr2021 whenever she woke up. With her cancer, she cannot sleep. After the second dose of the covid vaccine, she was so tired, she actually rested well. She was feeling yucky, with chills, a headache and a fever. She is grateful that she was able to get some sleep. It was completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Bad headache began on Saturday, 10Apr2021 whenever she woke up. Sleeping relieved her headache. She took some Tylenol even though she is not supposed to take Tylenol because of her chemotherapy. Tylenol could affect her liver because of the chemotherapy. She took the Tylenol for her fever and to help her headache. Her headache is on and off, but it is a lot better since her first headache. Her headache was the worst on the first day. She thought her symptoms were clear until her arm at the injection site was swollen, red and hurting. It was also hot to touch. Chills, body aches and fever of 99.4, 99.7, and 100.8, feeling unwell began on Saturday, 10Apr2021 whenever she woke up. Completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Her heart started racing on Saturday, 10Apr2021. Then it resolved on Sunday, 11Apr2021. Then her fast heartbeat came back whenever her arm at the injection site started to get swollen, red and hurting. She thinks that her fast heartbeat could be anxiety too. She has anxiety. She takes heart medications that are supposed to slow her heart down. The medications are not working. Chemotherapy makes her heart worse. She called her doctor about her heart beating fast. She has not heard back from her doctor yet. Usually her doctor will up her mediations. Now tomorrow, she will be filling her body with poison. Chemotherapy makes her heart worse. Chemotherapy name, lot number, NDC and expiration date: Not provided. The Pfizer covid vaccine made her heart worse. She is supposed to get chemotherapy tomorrow. She does not know what will happen tomorrow. She thinks that her doctor is going to have to up her medications. She has been seeing her heart doctor every week. Because of radiation, she has not seen her as much. She is going to see her heart doctor on Tuesday. Her heart doctor has been doctoring her for forever, and she sees her every week since she was diagnosed with cancer. She prefers for Pfizer to contact her heart doctor if there are any follow up questions. She had to have surgery, and after that she went into A-Flutter. Her heart doctor has been on it since. Clarified that her heart medications normally do work. She thinks that the COVID vaccine counteracted her heart medications. Normally her heart rate is under 100. After the COVID vaccine, at 7:00PM, her pulse was 104. On Saturday, at 4:30PM, her heart rate was 111. At 8:00PM, it was 109. On Sunday, it got better. At 7:30AM, it was 96. At 6:00PM, it was 90. On Tuesday, whenever the injection site turned red, was hurting and swollen, her heart rate was 104. Currently her heart rate is 94. She has A-Fib and A-Flutter. She has been doctoring that every week about that. After that she was fine. On Monday, 11Apr2021, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red, hurting and tender to touch. Her heart started beating fast again. The redness is the whole width of her arm. She is asking how long she can expect this redness to last. She does not know if radiation triggered this. It happened right after radiation that she started on Monday. Her daughter told her that this is normal, and a lot of people have this happen. The day before the second dose of the COVID vaccine, she had internal radiation. That was her third radiation treatment. She told her oncology doctor about the COVID vaccine and her doctor talked to her about it. Her doctor told her to go on and get the COVID vaccine, and that people like her needed the vaccine. She did not have radiation with first dose of the COVID vaccine. Therapeutic measures were taken as a result of bad headache and fever of 99.4, 99.7, and 100.8. The outcome of the events sickness, fever, chills, feeling abnormal, body aches and feeling unwell was recovered on 11Apr2021, headache was recovering, while of the rest was unknown.
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| 58 | 2021-04-30 | blood pressure increased |
difficulty breathing/breathing problems; increased blood pressure/blood pressure really high; itchin...
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difficulty breathing/breathing problems; increased blood pressure/blood pressure really high; itching incessantly; This is a spontaneous report from a contactable other health professional (patient) received via Medical Information Team. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 12Mar2021 at 09:30 (Lot Number: EN6198) (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included a couple of surgeries, prediabetic, breaking out with blisters on chin, hormone replacement, insomnia, muscle pain, blood pressure abnormal, depression, iron deficiency, allergies and itching, all from an unknown date and unknown if ongoing. Concomitant medications included metformin (formulation: tablet) oral at 500 mg once a day taken for prediabetic from 2019 and ongoing; acyclovir at 400 mg twice a day taken for breaking out with blisters on chin from an unspecified start date and ongoing; estradiol (formulation: tablet) at 1 mg once a day taken for hormone replacement from 2019 and ongoing; medroxyprogesterone acetate (PROVERA) at 2.5 mg once a day taken for hormone replacement therapy from 2019 and ongoing; trazodone HCl (formulation: tablet) at 100 mg once a day taken for insomnia from 2016 and ongoing; meloxicam at 15 mg once a day taken for muscle pain from 2016 to an unspecified stop date; hydrochlorothiazide at 50 mg once a day taken for blood pressure abnormal from 2016 and ongoing; buspirone (formulation: tablet) at 10 mg thrice a day taken for depression from 2016 and ongoing; ferrous sulfate (FEROSUL, formulation: tablet) at 65 mg twice a day taken for iron deficiency from 2016 and ongoing; cetirizine (formulation: tablet) at 10 mg once a day taken for allergies from Feb2021 and ongoing; hydroxyzine (formulation: tablet) oral at 25 mg taken for itching from Feb2021 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 19Feb2021 (Lot Number: EN6200) (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient reported that blood pressure was really high on 09Apr2021. On 10Apr2021 she woke up from sleeping due to difficulty breathing/breathing problems and went to the emergency room (ER) at 03:00. Caller stated they found out in the ER that her blood pressure was high. She stated that in the ER they didn't do anything but took her blood pressure and watched her blood pressure. Caller stated she was not admitted, she was there for 4 hours and sent home. Caller stated her blood pressure was over 200 and they still let her go home. Caller stated she went into the doctor on 12Apr2021 at 15:00 and got some medicine for the itching, at that time her blood pressure was down. Patient stated that itching could have been a reaction from one of the drugs she was given. Therapeutic measures were taken as a result of the blood pressure, the patient started a new medication, LOSARTAN at 50mg one time a day and got some medicine for the itching. The patient outcome of difficulty breathing/breathing problems and increased blood pressure/blood pressure really high was recovering and of itching was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6198), to reported events is possible. Tis case will be reassessed if follow-up information is received.
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| 58 | 2021-05-03 | lightheadedness |
Rash on face after first injection. Still have a rash. It comes and goes Shingles after 2nd shot. ...
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Rash on face after first injection. Still have a rash. It comes and goes Shingles after 2nd shot. Dizziness for two weeks. Near syncope 24 hours after shot. And 4 days later.
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| 58 | 2021-05-09 | blood pressure increased |
Blood pressure of 190 5 mins after injection of second dose. Blood pressure of 220 the following day...
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Blood pressure of 190 5 mins after injection of second dose. Blood pressure of 220 the following day. Blood pressure over 180 since injection everyday
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| 58 | 2021-05-10 | heart attack, heart attack |
I21.4 - NSTEMI (non-ST elevated myocardial infarction) K92.2 - Gastrointestinal hemorrhage, unspecif...
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I21.4 - NSTEMI (non-ST elevated myocardial infarction) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type
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| 58 | 2021-05-12 | hypertension |
Dizziness none stop 24/7; High blood pressure; High cholesterol; This is a spontaneous report from a...
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Dizziness none stop 24/7; High blood pressure; High cholesterol; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 at 11:00 (Batch/Lot Number: ER8737) at 58-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history included migraine, vertigo, and psoriasis; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received bnt162b2 for COVID-19 immunisation on 10Mar2021 (lot number: EN6207, administration time: 11:00, vaccine location: Right arm, dose number: 1); and morphine and ciprofloxacin and experienced allergy on an unspecified date. On 18Apr2021 at 04:00, the patient experienced: dizziness none stop 24/7, high blood pressure, and high cholesterol, and resulted in an emergency room/department or urgent care visit. The patient was hospitalized for the events from 18Apr2021 to 21Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: 197/133 in Apr2021, blood pressure measurement: high on 18Apr2021. Therapeutic measures were taken as a result of dizziness none stop 24/7, high blood pressure, and high cholesterol, which included losartan 50 mg and metoprolol 25 mg. It was reported that the patient was not stable on the medications. The clinical outcome of the events was not recovered. Since the vaccination, it was unknown if the patient had been tested for COVID-19.
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| 58 | 2021-05-13 | blood pressure increased, blood clot, nosebleed |
they packed my nose to stop it from bleeding, clots were coming out, clots coming both ways,; nose ...
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they packed my nose to stop it from bleeding, clots were coming out, clots coming both ways,; nose bleed; my blood pressure went up; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Mar2021 10:00 as 2nd dose ,single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Feb2021 for COVID-19 Immunization. The patient received the Second dose of Pfizer on 14Mar2021, states, "On 17Apr2021, Saturday, nose bleed started, and my blood pressure went up. I Called ambulance took blood pressure and it was 210/107. I didn't go to hospital, nose bleed had stopped while they were there, I stayed in ambulance until blood pressure came down. Sunday I went to ER (emergency room) because my nose started bleeding again, it stopped Sunday, but they checked the nose, nothing was there. I stayed in the hotel, Monday morning I blood again, Tuesday I bled even more starting at 7am and it didn't stop. Went to the hospital to ER (emergency room), they packed my nose to stop it from bleeding, clots were coming out, clots coming both ways, they checked blood, not anemic, everything okay with blood. on 23rd they removed the pack from nose, ENT told me no vessels were broken, he said I was fine. That is when I received a phone call about someone else having this problem. A week later a class mate said her sister had the same reaction after getting the Pfizer vaccine." She was calling about the Covid 19 vaccine. She received her second vaccine on 14Mar2021 and had no problems during that time. On 17Apr2021 she called an ambulance because she had a nosebleed. Her blood pressure was also high at that time around 210/107mmHg. Her nosebleed stopped with emergency management technicians and her blood pressure came back down. She did not go to the emergency room at this time. On 18Apr2021 at around 3:00AM, she had another nosebleed and she did go to the emergency department at about 10:00AM. She has never had a nosebleed before. When she was examined in the emergency room on 18Apr2021, she had no blood in her nose that the doctor could see. On 19Apr2021 around 7:00AM she had another nosebleed but the nosebleed stopped and she did not go back to the emergency room. On 20Apr2021, her nose started bleeding around 5:00AM and it didn t stop so she went back to the emergency room around 7:00AM and the doctor in the emergency room packed her left nostril and the blood was coming out of the right nostril and out of her mouth. She was bleeding for a few more minutes and then the bleeding stopped. Her blood pressure was fine. Her bloodwork was checked and everything was fine. She wasn t anemic or anything like that. She didn t have an bad effects from the nosebleeds. The emergency room told her to follow up with her primary care doctor on Thursday, 22Apr2021, but her primary care doctor no longer takes her insurance. She did go see an Ear, Nose, and Throat doctor on Friday, 23Apr2021. The Ear, Nose, and Throat doctor removed the nasal packing and examined the inside of her nose and told her that he could not see any broken vessels or any cause as to why she would be having nosebleeds. The patient's apartment is being renovated and she thought she might be having a reaction to the hotel she s staying in. She moved out of her apartment on 12Apr2021 and her nosebleeds started 17Apr2021. She has missed work because of her nosebleeds and she started back to work this week. When probing for her Covid 19 vaccine information she reports she does not have the vaccine record card with her. She received the second Covid 19 vaccine on 17Mar2021. NDC/Lot/Expiry not known. First Covid 19 vaccine date is in the suspect product field. She does not have the NDC/Lot/Expiry for the first date either. She reports she had a regular physical with her doctor in Nov2020. She received a tetanus vaccine at that visit. She reported she sometimes takes 2-3 regular Bayer Aspirin for minor pain. She took the Bayer Aspirin on Saturday, 17Apr2021, because she was going somewhere and she knew she would be sitting for a while at that place. She would like to report she experienced no discomfort, or aches or pains or headaches with her Covid 19 vaccine. There is no prior Vaccinations (within 4 weeks). The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476976 same reporter/drug/event, different patient
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| 59 | 2021-01-03 | hypertension |
Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after t...
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Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after taking again later. Contacted physician and advised to come in. Different BP med given that helped. Woke up tired the next morning.
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| 59 | 2021-01-04 | hypertension |
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t...
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Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol. Â Disposition: Patient declined ED visit
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| 59 | 2021-01-04 | heart rate increased |
after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just fel...
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after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms
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| 59 | 2021-01-05 | lightheadedness | Extreme Dizziness, Blurry Vision, Near fainting and Nausea |
| 59 | 2021-01-05 | chest discomfort, fast heart rate, lightheadedness |
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness...
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Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
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| 59 | 2021-01-06 | pulmonary embolism |
SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to cli...
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SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to clinic and saw a provider. Resulted in bilateral pulmonary emboli treated with Lovenox and Coumadin.
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| 59 | 2021-01-07 | fast heart rate |
Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tyleno...
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Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tylenol. Had to miss a day of work. Have lingering fatigue and headache after 2 days. Also morning after vaccination had about 5 minutes of tachycardia with HR of 165 bpm. Resolved after taking blood pressure which was 114/69 with HR of 85 bpm. No further episodes.
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| 59 | 2021-01-07 | blood pressure increased |
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes...
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From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
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| 59 | 2021-01-07 | palpitations, heart rate increased |
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ...
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Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
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| 59 | 2021-01-07 | palpitations, fast heart rate |
Tachycardia Narrative: VACCINE ADMINISTERED APPROX 1050AM, PT REPORTED PALPITATIONS AT APPROX 1102,...
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Tachycardia Narrative: VACCINE ADMINISTERED APPROX 1050AM, PT REPORTED PALPITATIONS AT APPROX 1102, VITAL SIGNS CHECKED, HER 110-120s, PT SENT TO ED VIA W/C ACCOMPANIED BY RN & MD
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| 59 | 2021-01-09 | chest discomfort, hypertension |
Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked th...
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Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked the next day was ok. Started driving the next day on interstate 12/25/20, and had chest pressure. Pulled of in to a hospital their and had testing done. Went home had dizziness still. Went to her MD, the doc changed her blood pressure meds. She doesn't have the dizziness and the chest pressure any more. Blood pressure is still high and monitoring it a few times a day.
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| 59 | 2021-01-10 | body temperature decreased |
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t...
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06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
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| 59 | 2021-01-10 | chest discomfort | Chest pressure. Took Tylenol |
| 59 | 2021-01-10 | chest discomfort |
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw...
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That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
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| 59 | 2021-01-11 | fainting |
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21...
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12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
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| 59 | 2021-01-11 | pallor |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | palpitations, blood glucose increased | Palpitations and anxiety. Resolved by the time she sought treatment in the ED. No rash, swelling. |
| 59 | 2021-01-11 | blood pressure increased |
patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID va...
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patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID vaccine - her blood pressure was elevated as well - she reports she had not taken her blood pressure medication prior to the vaccine. Patient received Acetaminophen and Lisinopril in Emergency Dept afterwards and discharged home.
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| 59 | 2021-01-11 | lightheadedness | pre syncope; difficulty breathing; dizzy - after 20 minutes of monitoring patient refused emt |
| 59 | 2021-01-12 | palpitations |
@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient h...
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@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take her medication this morning. With meds she is around 140s/80s. Stayed with us for about 30 minutes. Repeat vs 186/104 hr 68, 98% RA. Still reporting anxiety but states she feels her b/p is high because she is anxious. She never experienced SOB, difficulty breathing. Stated at first a little bit of a scratchy throat but that went away shortly after. She stayed until she felt less anxious.
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| 59 | 2021-01-12 | blood pressure decreased, fainting, body temperature decreased |
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou...
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Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
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| 59 | 2021-01-13 | hypertension |
About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue s...
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About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and then transported down to the emergency department. Upon arrival to the ED, she felt markedly improved with no symptoms other than some mild nausea. Patient was treated with steroids and ondansetron.
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| 59 | 2021-01-13 | chest pain, palpitations |
right after vaccine, she went to the observation area. Once there she stated having heart palpitati...
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right after vaccine, she went to the observation area. Once there she stated having heart palpitations and chest pain. She was taken to the ED for evaluation
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| 59 | 2021-01-14 | loss of consciousness |
On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started...
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On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.
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| 59 | 2021-01-14 | blood pressure increased |
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi...
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Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
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| 59 | 2021-01-14 | hypertension, fast heart rate | Tachycardia Hypertension (198/120) - no he of hypertension Lightheadedness |
| 59 | 2021-01-14 | lightheadedness |
Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie...
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Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie down on floor. Initial blood pressure reading approximately 5 minutes later was 92/54. Patient did not lose consciousness. Repeat blood pressure reading approximately 10 minutes after vaccine administration was 122/78 and patient reported feeling better. Patient was observed for an additional 20 minutes with improvement of symptoms.
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| 59 | 2021-01-17 | loss of consciousness, fast heart rate, fainting, palpitations |
20-30 min post injection, patient experienced tachycardia, palpitations, shortness of breath, syncop...
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20-30 min post injection, patient experienced tachycardia, palpitations, shortness of breath, syncope, loss of consciousness. 911 contacted by nursing home staff. Patient was placed in nursing home bed, 1 EpiPen dose administered by clinic nurse (RN. Nursing home staff began supportive care, supplemental oxygen given. patient experienced petit mal seizure and was non-responsive for a few minutes. Eventually came to but was still unstable. Paramedics took over at this point and patient was evaluated and transferred to hospital.
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| 59 | 2021-01-17 | heart attack, chest pain, heart attack |
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo...
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On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
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| 59 | 2021-01-18 | hypertension |
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden...
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Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
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| 59 | 2021-01-18 | chest pain |
Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper...
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Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper left back and up my lest side of next. Two days later I broke out in shingles. Dr put me in dexamethasone and famciclovir
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| 59 | 2021-01-19 | hypertension |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-19 | chest pain |
Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few second...
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Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few seconds of swallowing.
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| 59 | 2021-01-21 | chest discomfort, hypertension |
Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code bl...
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Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code blue was called, and the patient was taken to the emergency department for further workup. In the ED, the patient was evaluated for hypertension and chest pressure and subsequently discharged after a negative workup (normal EKG, normal troponin). On 1/17, the patient returned to the ED with complaints of numbness in the left arm from fingertips to elbow, with sensation slowly returning over the next 10 minutes. A head CT scan was performed, showing bilateral acute on chronic subdural hemorrhage (possibly related to fall patient reported having on 12/5/20 down 10 steps of stairs). The patient was eventually discharged on 1/19.
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| 59 | 2021-01-24 | heart rate increased |
Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink ...
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Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink of water, the subject felt the throat tightness becoming worse. The patient could talk but her voice wounded horse. Heart rate increased. After consulting with physician at vaccine administration site, patient was transferred to the emergency room for treatment. Blood pressure was 200/100 in the emergency room. Patient was treated with benadryl, steroids and pepcid. Patient recovered
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| 59 | 2021-01-24 | chest discomfort |
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ...
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soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
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| 59 | 2021-01-25 | chest discomfort |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-26 | heart rate increased |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | chest discomfort |
Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minute...
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Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minutes of injection, lasted approximately 30 minutes
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| 59 | 2021-01-26 | oxygen saturation decreased, chest pain |
Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, an...
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Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization. The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours. She is fine now. She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it. She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events. The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious Information on the lot/batch number has been requested.
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| 59 | 2021-01-26 | chest pain |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-28 | fast heart rate, blood pressure increased | 5 min after vaccine blood pressure 205/198 with tachycardia went to E.R. for 4 hours |
| 59 | 2021-01-28 | heart rate increased, blood pressure increased |
Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous repo...
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Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9261), via an unspecified route of administration on 15Jan2021, on 15:45 as the first single dose for an unspecified indication. Medical history included breast cancer from an unknown date, osteoarthritis from an unknown date, vasovagal syndrome from an unknown date, and sulfa allergy. Concomitant medication included ergocalciferol (VIT D), tocopherol (VIT E [TOCOPHEROL]), glucosamine (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC). The patient previously took cefalexin (KEFKEX) and experienced drug hypersensitivity, levofloxacin (LEVAQUIN), and experienced drug allergy. The patient experienced elevated heart rate on 15Jan2021, at 16:00 with outcome of recovered with sequelae; elevated blood pressure on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; lightheadedness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; shakiness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021. The patient recovered with lasting effects with no treatment. There was no Covid test post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement and heart rate which were elevated in 15Jan2021.
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| 59 | 2021-01-28 | fainting |
Patient fainted after receiving the vaccine. BP 95/75HR 100, O2Sat100%. PAtient was transferred to s...
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Patient fainted after receiving the vaccine. BP 95/75HR 100, O2Sat100%. PAtient was transferred to stretcher BP 106/65, HR 79, O2Sat 100% CAT team was called Patient was transferred to ED
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| 59 | 2021-01-28 | palpitations | Severe headache, palpitations, chills - started at 3am - lasted till 9pm |
| 59 | 2021-01-28 | pallor, fast heart rate |
The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pal...
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The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pale and blood pressure was 205/198 along with tachycardia. Spent hours in E.R.
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| 59 | 2021-01-29 | chest discomfort |
Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dos...
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Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dose administration into Right arm at 16:59. I took my albuterol inhaler, which did very little, so i added 20 mg prednisone tablet that i carry with me for emergency. Benadryl/Aleve mix (2 Aleve pm) taken at bedtime to assist in sleep and reaction. By 7:30 am i could not breath, peak flow meter revealed reduction to 68% capacity, so I took 60 mg prednisone, continued with albuterol inhaler q 4 hours,as i did the evening before. Then added Montelekust and allegra (antihistamine). Fever reached 99.4 degrees Fahrenheit, taken Temporal method- high for me, as i run low. An hour later, elevated temp to 100.5, same method, and has remained throughout the day and evening.
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| 59 | 2021-01-31 | heart rate decreased | Pulse dropped to 35 bpm, starting feeling better within 90 minutes |
| 59 | 2021-01-31 | coughing up blood |
temp 103/temp 99.9; severe headache; severe fatigue; muscle soreness; yellow nasal secretions; yello...
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temp 103/temp 99.9; severe headache; severe fatigue; muscle soreness; yellow nasal secretions; yellow and bloody sputum; yellow and bloody sputum; This is a spontaneous report from a contactable nurse. A 59-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284, expiry date unknown), intramuscular (right arm) on 12Jan2021 15:45, at single dose, for covid-19 immunization. The patient had no medical history and had no known allergies. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), on 21Dec2020 14:00 for covid-19 immunization, vaccine location left arm, at 59 years old. After 18 hours of obtaining shot, on 13Jan2021 09:00 the patient experienced temp 103, severe headache, severe fatigue, muscle soreness, yellow nasal secretions, yellow and bloody sputum. Now on day 4 after shot, 16Jan2021, the patient still had temp 99.9, headache, fatigue, nasal secretions and, sputum secretions less. No treatment was received for the adverse events reported. The patient was recovering from the events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post-vaccination.
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| 59 | 2021-02-02 | blood pressure increased, hypertension |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-02 | hypertension | Hi blood pressure, high blood sugar, weakness left side |
| 59 | 2021-02-02 | ischemic chest pain |
Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart p...
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Moderate anaphylaxis 1 hour after the injection which lasted for approximately 10 minutes. Heart pain and shortness of breathe which started within 15 minutes of the injection. The heart pains lasted 8-10 days. Headache, fatigue and shooting muscle pains throughout the body starting 2 hours after injection and lasting 8-10 days.
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| 59 | 2021-02-03 | palpitations, heart rate increased |
Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: ...
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Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: Rest, reassurance, warm water, HR down to 98. Stabilized.
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| 59 | 2021-02-04 | loss of consciousness |
Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tired...
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Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tiredness. I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad. I then developed a low fever and chills. Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5. I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
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| 59 | 2021-02-04 | blood pressure increased, chest pain, fast heart rate |
severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomac...
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severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomach pain, headache daily starting on 01/06/2021 to 01/27/2021; moderate generalized burning pain, tachycardia, elevated blood pressure 1/27/2021 to now; daily use Cymbalta for neuropathy pain; Amlodipine for high blood pressure; undergoing cardiology evaluation, continuing neurology visits; pending endocrinology evaluation
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| 59 | 2021-02-05 | hypotension | Headache, cold, fatigue, and low blood pressure. |
| 59 | 2021-02-06 | fibrin d dimer increased |
36 hours past the second vaccine, I started having shortness of breath which has not stopped since 1...
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36 hours past the second vaccine, I started having shortness of breath which has not stopped since 1/10/21. Required a trip to the emergency room, three specialists, and high-dose steroids. Treatment ongoing.
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| 59 | 2021-02-06 | hypertension |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
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| 59 | 2021-02-07 | blood pressure increased |
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry....
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Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
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| 59 | 2021-02-08 | chest discomfort, blood pressure increased |
Approximately 9 minutes post second vaccination EE developed chest tightness. Waited 30 minutes and ...
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Approximately 9 minutes post second vaccination EE developed chest tightness. Waited 30 minutes and was then ok. BP 130/85 HR 66. EE was provided a Benadryl to take if needed and escorted to elevator.
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| 59 | 2021-02-09 | heart rate increased |
High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130....
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High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130. Slept only 4 hours, feel shaky, and can feel pulse in neck and throat.
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| 59 | 2021-02-10 | palpitations |
1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately ...
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1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately an hour and then subsided.
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| 59 | 2021-02-10 | palpitations, hypotension |
12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, hear...
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12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, heart palpitations, low potassium. 2-3 hours symptoms lasted. Went to the ER; Oral potassium, juice to bring blood sugar up.
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| 59 | 2021-02-10 | chest pain, chest discomfort |
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug...
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7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
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| 59 | 2021-02-10 | palpitations |
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus...
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first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
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| 59 | 2021-02-10 | blood glucose increased | vertigo, nausea ,muscle pain general malaise, elevated blood sugars without eating anything. |
| 59 | 2021-02-14 | blood pressure increased |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
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| 59 | 2021-02-14 | heart rate increased |
Pt reporting feeling of elevated heart rate. PT BP 154/100, HR of 116, RR of 20 and GCS of 15. Pt ...
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Pt reporting feeling of elevated heart rate. PT BP 154/100, HR of 116, RR of 20 and GCS of 15. Pt stated history of anxiety. Pt symptoms resolved. Pt refused treatment or tx.
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| 59 | 2021-02-14 | nosebleed |
Received 2nd Covid vaccine on 1-22-21. The next day had muscle aches, fatigue(1-23). On 1-24-21 woke...
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Received 2nd Covid vaccine on 1-22-21. The next day had muscle aches, fatigue(1-23). On 1-24-21 woke up with 2 black eyes and a blood nose. This was about 8-8:30am. Blood nose lasted between one hour and one and a half hours. She packed her nose and by 10am it was not bleeding through and she left in place until 1pm. No more bleeding from nose after that time. All symptoms resolved by the end of the day 1-25-21. No more bleeding, denies bruising or any symptoms after that date.
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| 59 | 2021-02-15 | chest discomfort |
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ...
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Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
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| 59 | 2021-02-15 | palpitations, hypertension |
Individual developed palpitations and then high blood pressure on the day she received the COVID-19 ...
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Individual developed palpitations and then high blood pressure on the day she received the COVID-19 vaccine (1/4/21). She started having joint pain on the fourth day (1/7/21) and it lasted until 1/11/21. On 1/10/21, she couldn't stand to do dishes. She went to Urgent Care on 1/12/21.
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| 59 | 2021-02-15 | fainting |
Vaccine given at 1304. Patient reported feeling light headed and sweaty. Patient reported feeling ne...
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Vaccine given at 1304. Patient reported feeling light headed and sweaty. Patient reported feeling nervous. 1310: Patient tried to stand and felt really dizzy. Patient transported via wheelchair to lay down and then syncopal episode lasting 30 seconds. Patient transported to cot. 1318: Blood pressure, in right arm, 110/52, heart rate 88 and oxygen saturation level 98% on room air. 1328: Blood pressure, sitting, 92/48. Patient reports that she took all medications this morning and has been exercising more. 1333: Blood pressure, lying, 110/72, heart rate 85, and oxygen saturation level of 99% on room air. 1339: Patient attempted to sit up. "Feeling a little better." "I'm definitely cooling off. I'm not sweating anymore." 1341: Blood pressure, sitting, 100/68, in right arm. 1349: Blood pressure 118/760, sitting, in right arm
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| 59 | 2021-02-16 | fast heart rate |
Patient developed tachycardia almost immediately after she was given the vaccine. She recorded a he...
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Patient developed tachycardia almost immediately after she was given the vaccine. She recorded a heart rate of 142. She was further evaluated where she was noted to be dyspneic (diffuse wheezing in pt with history of asthma) and was noted to have a labile heart rate. Her heart rate increased from 80s at rest to 139 with ambulation. Given her dyspnea and very labile heart rate she was encouraged to go to the ED for further evaluation but patient declined. Cardiologist office alerted and she will follow up with him. EKG showing sinus tachycardia. Of note the pt is actively being treated for an arrythmia and recently adjusted her beta blocker.
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| 59 | 2021-02-17 | cerebrovascular accident |
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu...
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Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
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| 59 | 2021-02-19 | palpitations |
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,...
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On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
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| 59 | 2021-02-21 | fainting | Fainted on 2/11/2021, bowel incontinence, and vomiting |
| 59 | 2021-02-23 | oxygen saturation decreased, chest discomfort |
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest l...
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soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
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| 59 | 2021-02-24 | heart rate increased |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-25 | loss of consciousness |
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af...
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Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
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| 59 | 2021-02-27 | blood pressure increased |
Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, to...
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Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, took 50 mg of Benadryl. Medical staff on site recommended being checked out by an ambulance EMT crew, due to ongoing hives and very high blood pressure reading by them. Ambulance called by site medical personnel, ambulance crew strongly recommend transport to ER. Went in ambulance to Hospital ER. In ER for roughly 3.5 hours for observation and vital signs monitored until rash subsided and blood pressure went down.
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| 59 | 2021-02-28 | heart rate increased |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-03-01 | hypertension | Episodes of high blood pressure, treated with Amlodipine. |
| 59 | 2021-03-01 | chest pain, fainting |
PATIENT RECEIVED FIRST DOSE OF PFIZER VACCINE TODAY. AFTER 30 MINUTES OF OBSERVATION PATIENT COMPLAI...
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PATIENT RECEIVED FIRST DOSE OF PFIZER VACCINE TODAY. AFTER 30 MINUTES OF OBSERVATION PATIENT COMPLAINED OF FEELING FAINT AND HAD A SYNCOPALL EPISODE. PATIENT WAS ASSISTED TO THE FLOOR ,VITALS SIGNS TAKEN AND MONITORED BY HEALTH CARE PROFESSIONAL. PATIENT COMPLAINED OF CHEST PAIN BUT UNABLE TO RATE PAIN . AED MACHINE APPLIED PATIENT IN SINUS RYTHM WITH BP 130/90,HR 88 ,BLOOD GLUCOSE 102 AND SPO2% 99% ON ROOM AIR. 911 CALLED .PATIENT WAS ALERT AND TRANSPORTED TO MEDICAL CENTER BY EMERGENCY MEDICAL SERVICES
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| 59 | 2021-03-01 | inflammation of the pericardium, chest pain, arrhythmia |
i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with perica...
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i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with pericarditis. At the hospital, an EKG, echocardiogram, US of the abdomen, MRI of the chest, lab work, cardiac marker series , CRP and a scheduled exercised test was done that picked up arrhythmia. I am now recovering and I am still taking Colchicine, a gout medication that treats inflammation and pericarditis. I am on this medication till mid April 2021 when I see my cardiologist for follow up.
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| 59 | 2021-03-01 | palpitations |
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;...
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racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-03-03 | chest discomfort |
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ...
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her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
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| 59 | 2021-03-03 | palpitations |
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t...
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mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-03 | palpitations | shaky, nervous, palpitations. Evaluated by EMS-Cleared |
| 59 | 2021-03-04 | blood pressure increased |
Pt developed vertigo and high BP of 202/120. 1 hour after vaccine administration Went to Ed and fu...
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Pt developed vertigo and high BP of 202/120. 1 hour after vaccine administration Went to Ed and full neurological and lab work up completed. NO significant findings noted. NO medications or treatments administered. Follow up with PCP the next day was unremarkable. All symptoms resoled in 3 hours.
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| 59 | 2021-03-04 | blood pressure increased | Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded |
| 59 | 2021-03-06 | heart rate increased |
Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transp...
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Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transported to nearest ER.
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| 59 | 2021-03-06 | pallor | SOB, shaky, pale, cleared by medics. |
| 59 | 2021-03-07 | chest discomfort |
5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. ...
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5 mins after 1st dose Pfizer, pt c/o cough, SOB, tight chest, tingling of tongue & scratchy throat. EKG NSR. Pt DC home stable condition 11:42
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| 59 | 2021-03-07 | palpitations |
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ...
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Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
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| 59 | 2021-03-08 | loss of consciousness |
Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head w...
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Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
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| 59 | 2021-03-08 | vaginal haemorrhage |
She got the vaccine, started feeling like she thought was muscle pain and now that she thinks about ...
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She got the vaccine, started feeling like she thought was muscle pain and now that she thinks about it was menstrual cramps. Then some dark menstrual discharge. She thought it had stopped, but this afternoon had dark bloody clots/discharge when wiping. She is not having as bad of cramps. Sunday and morning were definitely worse days than today. She has not had a menstrual cycle in over 15 years, she is 60. She did not take anything for the pain. She is still having the symptoms, and actually worse than it was earlier.
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| 59 | 2021-03-09 | palpitations |
Within 24 hours patient developed generalized urticaria and a sensation of a racing heart. She took ...
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Within 24 hours patient developed generalized urticaria and a sensation of a racing heart. She took Benadryl and it took 2 and 1/2 days for the hives to resolve.
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| 59 | 2021-03-09 | cerebrovascular accident |
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ...
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having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
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| 59 | 2021-03-10 | hypertension |
Headache/High Blood Pressure. 186/101. May not be connected but mine is never high. I also couldn...
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Headache/High Blood Pressure. 186/101. May not be connected but mine is never high. I also couldn't sleep after injection, so maybe the excitement of getting the shot. Blood pressure progressively went down to normal with no treatment, in 1-2 days.
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| 59 | 2021-03-10 | chest discomfort, platelet count decreased, chest pain, blood glucose increased |
Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat ti...
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Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours. patient was sent to the ED by EMS. The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.
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| 59 | 2021-03-10 | body temperature decreased |
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre...
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Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
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| 59 | 2021-03-11 | heart rate increased |
I had a cardiac ablation done in Dec 2016 and had not experienced any symptoms until my first shot, ...
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I had a cardiac ablation done in Dec 2016 and had not experienced any symptoms until my first shot, which only caused one incident at the time of the first dosage, which went away within 30 minutes. Since the second dosage, I experience rapid heart rate immediately at the time of the vaccination, which occurs periodically, mainly in the late evening hours and during the night, causing me to be awaken. Pulse goes from normal mid-60 resting heart rate to low 100's. Dissipates after approximately 30-45 minutes. Working with Cardiologist to get a Halter Monitor to get details as the events happen. No treatment plan until they receive better data.
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| 59 | 2021-03-11 | fast heart rate |
SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vacci...
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SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vaccine (first dose) IM. Took to ED for evaluation. epinephrine 0.3 mg IM given in addition to methylprednisolone 125 mg IV and diphenhydramine 50 mg IV and famotidine 20 mg IV with a slight improvement in anxiety, throat tightness breath, however patient with persistent wheezing and cough. Albuterol 5 mg trialed without significant improvement in symptoms. Given persistent respiratory symptoms, repeat epinephrine 0.3 mg IM given with continued improvement in symptoms. Monitored patient for 4 hours and symptoms completely resolved. Discharged patient in care of granddaughter with outpatient epinephrine IM prescription.
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| 59 | 2021-03-12 | fainting |
During the night following the vaccination, I had chills, muscle aches and a headaceh. I got up to g...
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During the night following the vaccination, I had chills, muscle aches and a headaceh. I got up to go the batheroom and on the way back to bed I fainted and hit head on the floor.
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| 59 | 2021-03-12 | lightheadedness |
PATIENT REPORTED SHE BEGAN TO FEEL LIKE SHE WAS GOING TO VAGAL. EMS CAME OVER TO CHECK HER OUT AND ...
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PATIENT REPORTED SHE BEGAN TO FEEL LIKE SHE WAS GOING TO VAGAL. EMS CAME OVER TO CHECK HER OUT AND VITALS WERE NORMAL. SHE SAID SHE NEEDED TO GO TO THE BATHROOM, WAS ESCORTED TO THE RESTROOM AND HAD A BOWL MOVEMENT AND RECOVERED FINE
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| 59 | 2021-03-13 | nosebleed |
I experienced a nosebleed 4 1/2 weeks after the first Covid vaccination. I experienced a second nos...
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I experienced a nosebleed 4 1/2 weeks after the first Covid vaccination. I experienced a second nosebleed 3 days after my second Covid vaccination. Throughout my life, I have never experienced nosebleeds. I?ve reported this because this is VERY unusual for me.
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| 59 | 2021-03-14 | pallor |
3-11-21 5:11PM 'FEELS LIKE PASSING OUT'. PALE, SLIGHTLY DIAPHORETIC. 5:14PM MOVED TO COT IN SUPINE ...
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3-11-21 5:11PM 'FEELS LIKE PASSING OUT'. PALE, SLIGHTLY DIAPHORETIC. 5:14PM MOVED TO COT IN SUPINE POSITION- FEELING BETTER. A/O, PINK, W/D. 5:21PM 'FEELS 100% BETTER NOW'. NO PAIN NO SOB. 5:35PM HUSBAND HERE TO DRIVE PT HOME - PT AMBU TO EXIT- GAIT BRI SK AND STEADY. NO ACUTE/OBVIOUS DISTRESS NOTED. 3-12-21 9:45AM TC: PT STATES SHE 'FEELS BETTER - FULL RECOVERY'.
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| 59 | 2021-03-14 | heart rate increased, chest discomfort |
Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think ...
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Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think my heart rate was due to anxiety about the vaccine . That was until Friday morning. I woke up on the 5th at around 1 am shaking . Then got the cold sweats and chills and then burning up and body aching. Then I started throwing up. I started taking some IBProfen which helped with the fever and shakes. Stayed in bed all day and drank water. My heart rate was up to 122 bpm while I was laying on the couch. I was tracking it with my Apple Watch. I stayed on the couch for the next 2 days and Sunday I started feeling better. Each day I was feeling better but now almost two weeks out I still get slight headaches off and on, I have no energy and get the chills and my chest has a heavy feeling. But I don?t feel short of breath. I took a rapid covid test today 3/15/21 and the results were negative for covid and the flu. I am going to see a doctor on wed. as I am not sure I should get the second dose.
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| 59 | 2021-03-15 | palpitations |
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar...
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Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
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| 59 | 2021-03-15 | blood pressure increased |
Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by parame...
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Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by paramedics on site. Monitored patient for 30 minutes. Patient referred to ER due to elevated BP. Patient refused and signed AMA. Patient A&O x3, accompanied by husband.
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| 59 | 2021-03-16 | chest pain | Nausea, upper abdominal pain, chest pain, liver pain, back pain. |
| 59 | 2021-03-16 | hypertension, chest discomfort | Persistent chest pressure, elevated blood pressure, transported to ED |
| 59 | 2021-03-16 | palpitations, blood pressure increased, heart flutter |
Within 2 minutes of receiving the vaccine, my heart started racing and was fluttering. Within an hou...
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Within 2 minutes of receiving the vaccine, my heart started racing and was fluttering. Within an hour, my heart would not stop racing (HR 115-120) and my blood pressure was increasing. It reached 184/121 with a HR of 130 and I took an additional 5 mg of Lisinopril. I developed a severe headache and mild nausea. 6 hours after the vaccine I went to urgent care because my BP would not not go down lower than approximately 180/100. Once the diastolic got under 100 at urgent care facility, they sent me home. My BP and heart rate were elevated for 3 days while I continued to take extra Lisinopril each day. I feel that I am having a lasting affect as I continue to take an additional 2.5 mg of lisinopril to keep my BP down, and it is still a little higher than usual. On March 15th I returned for 2nd dose and was refused due to adverse affect. I went to cardiologist that day and she felt it was an allergic reaction. My allergist does not view it as an allergic reaction, just an adverse affect.
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| 59 | 2021-03-17 | chest discomfort |
Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER ...
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Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER at 1:52, Released at 4:00 pm
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| 59 | 2021-03-18 | loss of consciousness |
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar...
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(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
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| 59 | 2021-03-18 | palpitations |
48 hrs after vaccine got palpatations and dizzy then 1 week later developed transaminitis and has li...
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48 hrs after vaccine got palpatations and dizzy then 1 week later developed transaminitis and has liver issues and possible hepatitis
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| 59 | 2021-03-18 | palpitations, chest discomfort |
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my...
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About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
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| 59 | 2021-03-19 | palpitations, chest discomfort |
Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Conges...
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Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Congestion Muscle/Joint Pain
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| 59 | 2021-03-21 | chest discomfort |
Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches...
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Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches, arm pain. Mild vaccine reaction, follow up with PCP.
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| 59 | 2021-03-21 | blood pressure increased |
Shortly after receiving vaccine, the patient began to experience lightheadedness. Vital signs taken...
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Shortly after receiving vaccine, the patient began to experience lightheadedness. Vital signs taken and within normal limits except for slight increased blood pressure. Cleared medically.
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| 59 | 2021-03-22 | fainting | ?Fainting, ?body chills, ?fever, ?loss of appetite, ?weakness, ?sleepiness, ?headaches |
| 59 | 2021-03-22 | chest pain, palpitations |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM E...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM Expand AllCollapse All COVID VACCINE CLINIC 3/19/2021 Patient: DOB: Date: 3/19/2021 MRN: Subjective Patient is a 59 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience heart racing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: insignificant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Heart racing onset 5 minutes after injection. Briefly lasted. Resolved by the time she arrived to the medical bay. NO other symptoms reported. : She ate lunch today. Previous Reactions: none Objective Vitals Vitals: 03/19/21 1412 03/19/21 1422 BP: 137/80 129/65 BP Location: Right arm Pulse: 92 SpO2: 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and close monitoring until end of her observation time. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Possible anxiety flare up. Resolution of symptoms by the time of arrival to bay. Pt feels well. She is appreciative of her care today. APRN Electronically Signed 3/19/2021 2:31 PM
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| 59 | 2021-03-22 | palpitations |
Report of racing heartbeat HR 120 Alert Vitals obtained and client stable Discharged to home Fo...
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Report of racing heartbeat HR 120 Alert Vitals obtained and client stable Discharged to home Follow up call feeling much better
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| 59 | 2021-03-22 | hypertension |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-03-22 | hypotension |
Systemic: Dizziness / Lightheadness-Mild, Systemic: LOW BLOOD PRESSURE-Mild, Systemic: Hypotension-M...
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Systemic: Dizziness / Lightheadness-Mild, Systemic: LOW BLOOD PRESSURE-Mild, Systemic: Hypotension-Medium, Additional Details: Her Blood pressure was 87/90 when she complained about dizziness.
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| 59 | 2021-03-22 | chest pain | shortness of breath chest pain respiratory failure with hypoxia multifocal pnuemonia |
| 59 | 2021-03-23 | hypotension, heart rate decreased |
16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. ...
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16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. I asked to go outside and was told no. I moved from back to the front as i felt cold and was swearing. It was sift chsnge and the staff was huddled in a corner and i called for help.2x before taking off my mask amd callinf a thried time. By this point i felt like vomiting and nedded immediate water. The thirst was intrnse. The University of Arizona didn't have anything for me to throw-up into except a half full used large janitorial garbage can. I was given water and that really helped the thirst and nausea. The nurse came and put a monitor on my finger and immediately took me to a back area where rhe cold sweat and chills now covered my whole body and the thirst returned. Tje nurse took my vitals and i remember my heartbeat reading in the 30s and had a very low blood pressure. No one ever experienced what was happening and i asked if i was going to die. The only thing they had to lie down on was an army cot 6" off rhe ground. I wanted to lie down so badly buy it had no sheets, pillow or anything. With all the money they get from the feds they should be able to afford a gurney. I was never told the truth about what had happened to me. I was let go with a very low heart rate of 51. My normal is 68 to 78. No follow up instructions.
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| 59 | 2021-03-23 | heart rate increased, palpitations |
Fast heartbeat at bedtime. I received the vaccination at 12:40pm, but heart palpitations started at ...
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Fast heartbeat at bedtime. I received the vaccination at 12:40pm, but heart palpitations started at bedtime, around 11: 00pm on same day of vaccination, March 21, 2021.
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| 59 | 2021-03-24 | hypertension |
10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arm...
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10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arms and hands. Skin mottled and red) Then Blood pressure observed to be was high Then hives and itching developed Then Dizziness occurred Then nurses took me from shot clinic to the ER All above symptoms within 30 minutes of shot About 9 pm experienced swollen and painful veins in left arm (shot was in right arm) as of 7pm next day still painful veins in left arm.
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| 59 | 2021-03-24 | heart rate increased |
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
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| 59 | 2021-03-24 | chest pain | Arm pain Left chest pain Difficulty breathing |
| 59 | 2021-03-24 | chest discomfort |
Client reported some feeling in the center of her chest said it was not pain, she just felt somethin...
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Client reported some feeling in the center of her chest said it was not pain, she just felt something and she was dizzy. 10:34 b/p110/62 Pso2 99% pulse 76 Respirations even and unlabored. Skin pink warm and dry. Re check feeling better not dizzy Pso2 98% pulse 65 10:39 symptoms gone Pso2 99% pulse 66 b/p 106/64 Patient monitored a little further then released.
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| 59 | 2021-03-24 | palpitations |
Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon a...
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Heart pounding, lips swelling (reported). Pt did not appear to be swollen, pt " felt better" soon after assessment. Pt refused transport to hospital.
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| 59 | 2021-03-24 | heart rate increased |
I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, ...
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I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping, and slight headache for about 3 or 4 days. Then, I was having sharp, severe shooting pains in my ring finger and elbow. I talked to my primary care doctor's office 3 times. I went to the emergency room on Thursday, March 18th. The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc. I also had a COVID-19 test on both March 18th and March 21st. They were both negative.
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| 59 | 2021-03-24 | palpitations |
Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vac...
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Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vaccine. She has a history of well controlled psoriasis BSA 2-3%, today she a rash that is not consistent with psoriasis. Rash presented within 12 hours of vaccine administration. Additionally, she reports within the first 12 hours of second vaccine administration she developed extreme anxiety, shortness of breath, anxiety, and heart palpitations that lasted intermittently for 2 days. She did not seek medical attention. On exam she is alert/oriented, no visible distress. Pending skin biopsy results.
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| 59 | 2021-03-24 | blood pressure increased |
Two and a half hours after I received my shot, and while at rest, I noticed what looked like a blu...
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Two and a half hours after I received my shot, and while at rest, I noticed what looked like a blue line 2cm long on my left hand on the crease where my thumb meets the palm. The abductor briefly turned blue. The veins on the back of both hands and both wrists were protruding/bulging significantly. This morning the bulging veins had mostly abated. There is still a faint blue line at the crease of my thumb, but it is now 1 cm long. At no time did I feel dizzy or faint.
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| 59 | 2021-03-24 | cardiac arrhythmia, heart rate increased |
patient experienced rapid heartbeat and a rash that spread down her arm and a bit of shortness of br...
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patient experienced rapid heartbeat and a rash that spread down her arm and a bit of shortness of breath. Started appx 15 minutes after vaccine, applied cool compress called 911 and observed patient. Paramedics did note PVC abnormalities on patient EKG and advised her to take 50 mg of Benadryl and follow up with medical care
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| 59 | 2021-03-25 | palpitations |
15 min after vac pt c/o dizziness, stated I feel like heart is racing, shaky, sweating . EMS whe...
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15 min after vac pt c/o dizziness, stated I feel like heart is racing, shaky, sweating . EMS wheeled to recovery booth. Assess: no LOC, no N/V, Rt deltoid site benign. VS 148/88, HR 91 reg strong, resp 18 reg non-labored, SpO2 99%. . BS taken by ems 106, cold pack placed to back and front of neck pt stated she did not eat or drink today. Checked left port site for CLL benign. Monitored for 40 min, gave water for hydration. dizziness & diaphorsis subsided. 10:10 VS 132/86, HR 85, Resp 12, SpO2 98%. No further complaints. After 40 minutes pt stated I feel ok to leave and walked out. Ok'd to exit. S Reagan RN
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| 59 | 2021-03-25 | low platelet count | thrombocytopenia |
| 59 | 2021-03-26 | chest pain |
I received my vaccine on the 25th at 8:50 a.m. At 4:00 a.m. on the 26th, I woke up with a pain in m...
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I received my vaccine on the 25th at 8:50 a.m. At 4:00 a.m. on the 26th, I woke up with a pain in my chest that wasn't too bad, and a slight headache. I got up and went to the bathroom and took my temperature. It was 101.9. I went back to bed and the pain in my chest felt like a spasm at the base of my esophagus. It would come and go and I thought it might be indigestion or something but it coincided with when my temperature started. I had woken up a few times before 4:00 and felt chilled but had taken my temp and I didn't have any. Over the course of the next few hours, the pain got more and more intense to the point my husband felt we should go to the emergency room. When it would be in my chest area, it was excruciating. It would alternate between the center of my chest and then would be in the center of my back between my shoulder blades. I took five or six Tums over this period of time. I took two Tylenol at around 5:30 a.m. The episodes lasted several minutes, would ease a little and then start up again. My temp started to come down around 6:00 but was still 100.1. The pain in my chest felt like a spasm type pain, but when it would go to my back, that was a fairly constant pain. I finally agreed to go to the emergency room and my husband helped me get dressed. This was about 6:30 a.m. Shortly after that, the episodes started spreading out to where they weren't as long or frequent. About 7:45 a.m. they had eased up completely, and I took my temp again at that time, and it was completely normal. We did not end up going to the emergency room. The pain did not come back for the rest of the day.
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| 59 | 2021-03-26 | chest pain |
Moderate Pain in right armpit radiated to sternum and lower rib cage on right side. Sporadic headach...
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Moderate Pain in right armpit radiated to sternum and lower rib cage on right side. Sporadic headache. Sweating but no fever (anxiousness perhaps??). Felt fine next day, some soreness at injection site remained.
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| 59 | 2021-03-26 | heart rate increased |
On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwis...
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On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwise I felt fine. 5 days after receiving the vaccination I noticed I was dizzy when standing up in the AM. Late AM I developed a headache which got more severe in the afternoon through the evening and was accompanied by nausea, chills, briefly high heart rate (199), fatigue, and the dizziness. Took 2 Tylenol in the evening . 2 hrs later symptoms improved dramatically. Felt a little unsteady today.
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| 59 | 2021-03-26 | chest discomfort |
Received Pfizer vaccine at 0827 and was instructed by LVN to wait 30 minutes post vaccination for ob...
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Received Pfizer vaccine at 0827 and was instructed by LVN to wait 30 minutes post vaccination for observation. Patient complains of throat swelling and chest tightness approx 40 minutes post vaccination. On exam, no lip or throat swelling noted. Denies headaches, shortness of breath, dizziness, rash, itching. Patient speaking in full sentences, respirations even and unlabored. BP 131/83, pulse 82, O2 sat 100% 0925 Benadryl 25mg by mouth given. Patient remained alert and oriented, speaking in full sentences. BP 128/76, pulse 76, O2 sat 99% Patient continues to complain of chest tightness; throat swelling mildly improved per patient. History of asthma- instructed to use albuterol inhaler 2 puffs at 0930. 0935 Transported via wheelchair to UC for further evaluation.
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| 59 | 2021-03-26 | hypertension, chest pain, chest discomfort |
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif...
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Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
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| 59 | 2021-03-26 | blood pressure increased | nauseated, dizzy, elevated BP |
| 59 | 2021-03-26 | palpitations | palpitations, tingling over lips, rash |
| 59 | 2021-03-27 | blood clot |
Blood clots a few weeks after 2nd dose. Currently being treated with Xarelto. No other changes in pa...
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Blood clots a few weeks after 2nd dose. Currently being treated with Xarelto. No other changes in patient medical or prescription history. Covid vaccine was the only thing that was new. Patient had no prior history of blood clots.
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| 59 | 2021-03-27 | heart rate increased, hypertension | SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE, FAST HEART RATE, TINGLING IN FACE |
| 59 | 2021-03-28 | chest discomfort, chest pain |
Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated wit...
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Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea. 3/10/2021 dev fever, weakness, and cough. Covid test 3/12/2021 neg. Eval in walk in clinic. Diag allergies. Rx oral steroid and Amoxicillin. A couple of days later, symptoms still continued. Eval in her physician's office 3/18/2021. Given steroid injection and antibiotic changed to Azithromycin. 3/19/2021 felt worse with pain/pressure under ribs and upper abd. eval in ER. O2 sat 87 improved to 93 with oxygen. Labs, chest xray, and CT scan obtained. Covid test neg. Admitted to hosp with diag of bilat pneumonia. Discharged on 3/22/2921 with steroids to take over next 5 days. She continues to have mild cough and pressure under her lower ribs. F/u appt scheduled with her physician. Was advised by her physician her pneumonia might be a reaction to the vaccine.
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| 59 | 2021-03-28 | low blood oxigenation |
Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to ...
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Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to staff at the care home. leukopenia, pulmonary edema, death
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| 59 | 2021-03-28 | heart rate increased |
Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-P...
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Patient experienced swelling of bottom lip first. This was followed by labored breathing. An Epi-Pen (branded generic form) was administered in addition to two diphenhydramine 25mg tablets. Patient was given a bottle of water. Over the course of approximately 7 minutes she consumed about one-half of the bottle. Paramedics were called. Prior to their arrival at 9:47 AM, the patient experienced additional swelling of lips, this time the top, and labored breathing. Another Epi-Pen was administered. Patient reported some elevated heart rate and mild headache, probably as a result of the epinephrine administration. She was transported to hospital at 9:49 AM.
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| 59 | 2021-03-29 | palpitations, heart rate increased, blood pressure increased |
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1...
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immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache. By 4th hour I needed to go to bed.
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| 59 | 2021-03-30 | platelet count decreased, low blood platelet count |
Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood d...
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Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
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| 59 | 2021-03-30 | loss of consciousness |
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;...
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When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
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| 59 | 2021-03-30 | chest discomfort, chest pain |
coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild alle...
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coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 59 | 2021-04-01 | fainting |
Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneo...
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Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on batch/lot number was requested.
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| 59 | 2021-04-01 | cerebral haemorrhage | Patient died of a cerebral hemorrhage on 3/15/2021 at 11:30 AM. |
| 59 | 2021-04-02 | chest pain, cardio-respiratory arrest, cardiac arrest |
brought in by EMS due to code. Started as CP and proceeded to cardiac arrest. Went into Vtach twice...
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brought in by EMS due to code. Started as CP and proceeded to cardiac arrest. Went into Vtach twice in the field. No cardiac issues other than HTN & afib. Per ED note, received COVID vaccine yesterday
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| 59 | 2021-04-03 | heart rate increased |
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li...
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eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-04-06 | oxygen saturation decreased |
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low...
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O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
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| 59 | 2021-04-06 | palpitations |
Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional h...
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Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional heart palpitations that lasted first 4 days then stopped--heart returned to normal with no more episodes. On 2/4/21, that night when I went to bed, I noticed a ringing in my left ear that became louder & louder as the next several days went by. I then noticed substantial hearing loss in my left ear. Also 2 days later, I started having a dull ache around my left ear along with the loud, high pitched ringing. I kept thinking it would get better but a week before my next vaccine, I called my ENT who monitors a small lesion & hearing in my left middle ear. I already had slight conductive hearing loss from this lesion and my last appointment/check up with her was in September 2020. Dr. had me come to the hospital on 3/11/21 and a hearing test was performed and my left ear hearing had declined 15 decibels since my last hearing test in Sept 2020. I was prescribed a Medrol Pak (steroids) for 1 week and returned on 3/23 for a 2nd hearing test with no improvement in my hearing or the loud ringing (tinnitus). The Dr. told me that my hearing test showed damage to the left ear nerve. I had also developed an inflamed, painful large sore under the left side of my tongue & was prescribed Triamcinolone Acetonide Dental Paste to use 2 x daily on the sore. The Dr. ordered an MRI of my brain & left ear to make sure the lesion in my ear had not grown. I had the MRI on 3/29/21 and returned to my Dr. on 3/30/21 for results. The lesion was stable, no growth. I made my own decision and did not return for my 2nd Covid vaccine because it appears the 1st vaccine either inflamed the nerve in my ear or caused an auto immune response.
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| 59 | 2021-04-06 | blood pressure decreased |
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe...
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head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
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| 59 | 2021-04-07 | loss of consciousness |
passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable con...
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passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
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| 59 | 2021-04-12 | fibrin d dimer increased, chest discomfort, pulmonary embolism |
To summarize our conversation, you stated that you received the second Pfizer vaccine on 3/4/21. Th...
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To summarize our conversation, you stated that you received the second Pfizer vaccine on 3/4/21. Three days later, on 3/7/21, you began to have fatigue, shortness of breath, dizziness and chest pressure. Because all symptoms continued for 24 hours, on the evening of 3/8/21, you took yourself to the Emergency Department. Your ER work-up included a CXR (negative), an EKG (showing a left bundle branch block), serum bloodwork (negative for MI), however, the D-dimer and spiral CT were both positive for a pulmonary emboli (i.e. a blood clot in your lungs). You were admitted to the hospital and started on the blood thinner, Eliquis. During your 3-day hospital stay, your work-up also included a bilateral lower extremity Doppler study (negative) and an echocardiogram (showing left ventricular hypertrophy). You were discharged on all of your previously prescribed medications (see list below), except for the fish oil. You were also started on Eliquis. Since discharge, you have followed up with your PCP and have been referred to a cardiologist and pulmonologist. To date, you have had no further symptoms. PAST MEDICAL HISTORY: hypertension, hypercholesterolemia, pre-diabetes. PRE-VACCINE MEDICATIONS: losartan, HCTZ, amlodipine, Welchol, fenofibrate, fish oil. POST-ER VISIT MEDICATIONS: losartan, HCTZ, amlodipine, Welchol, fenofibrate, Eliquis.
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| 59 | 2021-04-13 | blood pressure decreased | Within two days. Drop in blood pressure and then severe vertigo |
| 59 | 2021-04-16 | cerebrovascular accident | Severe headache Vomiting profusely Stroke |
| 59 | 2021-04-17 | cardiac failure congestive |
Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chroni...
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Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chronic obstructive pulmonary disease; Arm was killing her all the way down/her arm hurt so bad/ left leg hurts from her knee to her hip; Chills; Headache; Left leg hurts from her knee to her hip; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Lot Number: ENB207), via an unspecified route of administration, administered in right arm on 19Mar2021 08:00 AM (at the age of 59-year-old) as single dose for COVID-19 immunization. Medical history included asthma since 1990, obese since 1990, Congestive heart failure about 4 years ago in 2017, Chronic obstructive pulmonary disease since 1989; all were ongoing. She had a chemical exposure in a small town that started the COPD since about 1989. Concomitant medications were not reported. The patient previously received fluzone on unspecified date for flu vaccine and caused COPD exacerbation, she was given doxycycline and prednisone with that. The patient is calling about the Pfizer Covid 19, her first dose she received on 19Mar2021. She isn't going to take the second Covid 19 vaccine. On 19Mar2021 at 7:00PM on the day she received her Covid 19 vaccine her arm was killing her all the way down/ arm hurt so bad she wanted to cut it off. That lasted the whole next day and she took 2 Tylenol arthritis pills. Her arm was real sore the next day but it wasn't paining her like it was that first day. It was still a little sore but not like it was. The pain was down the whole arm. Last week (on unspecified date in Mar2021), she started getting headaches and chills. She'll get a chill and the chill will go away. Then a couple hours later the chills will come back. Her headache comes and goes. She checked her blood pressure and her blood pressure is normally low, she checked it and it was 117/76 in 2021. She knew her blood pressure wasn't causing her headaches. And she checked her oxygen level on unspecified date in 2021 and it was good. She normally does not have headaches. She's on 4L of oxygen because of congestive heart failure and chronic obstructive pulmonary disease. Her breathing has been, she can't describe it. Her doctor prescribed some steroids yesterday, 30Mar2021. She is asking if this is normal after 2 weeks. When asking her about her breathing she reports it's like her chest is tighter and she has shortness of breath. If she moves, her oxygen level on unspecified date in 2021 drops with the slightest little movement. Her oxygen has been dropping into the 70s and she has to do the pursed lips breathing to recover. It's taking a while to recover. She has to really work to get her oxygen back into the 90s. That started last week some time. She did call her doctor and her doctor prescribed prednisone and doxycycline (Prednisone 4, 10 mg tablets for 3 days, then 3 tablets for 3 days, then 2 tablets for 3 days, then 1 tablet for 3 days and Doxycline Hyclate 100mg 1 capsule twice daily for 7 days). She forgot to mention that her left leg hurts from her knee to her hip on unspecified date in 2021. That started a couple days ago. She didn't have any problems with her hip before. She's scared because the second vaccine is more potent, it's worse. She doesn't know if she's going to get that second Covid 19 vaccine. The outcome of the events was not recovered.
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| 59 | 2021-04-17 | heart attack, hypertension, chest pain |
chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a con...
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chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 09:15 at single dose in left arm for COVID-19 immunization. Medical history included Irregular heart beat. The patient had no Allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN), and metoprolol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Monday morning (29Mar2021 06:45), when the patient got out of bed she started having chest pain, took a shower and the pain got worse like she was having a heart attack, she was admitted to the hospital and treated for the pain and had EKG, stress test done, blood pressure was high, and she had a very bad headache; The events resulted Emergency room/department or urgent care. Tuesday morning (30Mar2021) the pain started to decreased and after another EKG and her blood pressure went down she was released and advised to follow up with her primary doctor as well as the cardiologist. Lab test included Nasal swab negative on 29Mar2021. Treatment was received for all events. The outcome of all events was resolved. Information on the lot/batch number has been requested.
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| 59 | 2021-04-22 | heart rate increased |
Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure ...
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Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; Anxiety; Eye felt red; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: E10142), dose 1 via an unspecified route of administration, administered in left arm on 14jan2021 at 09:00 as single dose for covid-19 immunisation. Medical history included vitamin supplementation, supplementation therapy, cataract (Mother had cataracts; problems with her heart; had a couple of strokes before she died at 59 years of age), cardiac disorder, cerebrovascular accident, pain (Before she had the first dose of Pfizer COVID-19 Vaccine she was not so concerned because she figured she would probably get body aches or headaches, normal side effects), headache, normal side effects. Concomitant medications included ergocalciferol (vitamin d [ergocalciferol), krill oil (megared omega 3 krill oil), vitamin c [ascorbic acid], nigella sativa seed (black seed [nigella sativa seed]), betacarotene, calcium carbonate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, sodium ascorbate, thiamine hydrochloride, tocopheryl acetate (one-a-day vitamin), cyanocobalamin (vitamin b12 [cyanocobalamin]), acetylsalicylic acid (baby aspirin), calcium, magnesium, zinc (magnesium/calcium/zinc) taken for vitamin supplementation and probiotics taken for supplementation therapy. No any other vaccinations within 4 weeks Prior to the first administration. No AE(s) following prior vaccinations: although she did get unknown Shingles vaccine in Sep2020, no AEs associated. She has not gone to get the second Shingles vaccine because she does not want to overlap vaccines while getting Pfizer COVID-19 Vaccine. The patient Was concerned for her 2nd dose which she was scheduled to take tomorrow on 02Feb2021 at 14:30, because of the side effects from her 1st dose. On 15Jan2020, a day after the 1st dose, her heart started pumping really hard and she had a fast heartbeat/ heart fluttering a lot. She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye. She it was strange because this has never happened to her before up until she got the vaccine. She consulted her eye doctor and mentioned that she will be monitored for the pressure in her right eye. She is also getting anxiety because of this. She was asking if she can go tomorrow to take the 2nd shot. The outcome of events her heart started pumping really hard, she also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye, anxiety and eye felt red was unknow where the outcome of events fast heartbeat/heart fluttering a lot was not recovered. Follow-up attempts are completed. No further information is expected.
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| 59 | 2021-04-24 | hypertension |
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got...
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Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
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| 59 | 2021-04-26 | fainting |
A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficul...
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A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficulty breathing; had a horrific taste in my mouth; A nurse saw me in distress & caught me before I hit the floor; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 11Apr2021 at 11:15 (batch/lot number: EP7533) as a single dose for COVID-19 immunisation. Medical history included cancer history, back injury, right shoulder injury; and known allergies to sulfa, IVP dye, latex, bee stings and mushrooms. The patient was not pregnant. Facility type vaccine was health clinic. No other vaccine in four weeks. No Covid prior to vaccination and not Covid tested post vaccination. Concomitant medications in two weeks included gabapentin, valaciclovir, tramadol, doxycycline and vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, morphine and hydromorphone hcl (DILAUDID) and experienced known allergies to all drugs. On 11Apr2021 at 11:30, also reported as within 2 minutes of getting the vaccine, the patient had a horrific taste in her mouth followed by dizziness & lightheadedness. A nurse saw her in distress & caught her before she hit the floor. She then had difficulty breathing. They administered EpiPen, 50 mg liquid Benadryl & 2 puffs of Ventolin. She was transported to the ER by ambulance. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
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| 59 | 2021-04-26 | hypertension |
Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low ...
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Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low grade fever. I took Tylenol and the chills and fever went away Friday night, The pain in my arm went away by Sunday, 4/25. My blood pressure went down after drinking more water. I can still feel the lump but its not as painful.
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| 59 | 2021-04-26 | cardiac arrhythmia, pulmonary embolism |
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p...
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to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-27 | blood pressure decreased |
vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patie...
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vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 22Mar2021 at 16:00 (Lot Number: EN6206) (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, gastrooesophageal reflux disease (GERD), iodine allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe blood pressure drop on 24Mar2021 at 07:00 and vertigo on 26Mar2021, which caused hospitalization from 27Mar2021 to 03Apr2021 for 7 days. It was reported that the severe blood pressure drop occurred two days after vaccination and two days later, vertigo occurred. The patient underwent lab tests and procedures which included blood pressure: drop on 24Mar2021, COVID PCR (nasal swab): negative on 29Mar2021, and COVID PCR (blood test): negative on 04Apr2021. Therapeutic measures were taken as a result of the events, which included unspecified blood pressure medication, unspecified vertigo medication, and intravenous (IV) fluids. The clinical outcome of severe blood pressure drop and vertigo was not recovered.
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| 59 | 2021-04-28 | lightheadedness, loss of consciousness |
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;...
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Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
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| 59 | 2021-04-28 | chest discomfort |
Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer p...
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Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer plus cold and flu evervescent tablets. Waiting to see if works.
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| 59 | 2021-04-28 | chest discomfort |
Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold ...
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Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold and flu effervescent tablets. Waiting on results.
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| 59 | 2021-04-28 | blood clot |
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern...
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blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.
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| 59 | 2021-04-30 | hypertension, blood pressure increased, body temperature decreased |
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure;...
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Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-30 | heart flutter |
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he...
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they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
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| 59 | 2021-05-07 | loss of consciousness |
Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This ...
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Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation and asthmatic. The patient's medical history included rheumatoid arthritis (diagnosed three months ago), sleep disorder, blood pressure, blood pressure increased, PTSD (post-traumatic stress disorder). Patient's medical history (including any illness at time of vaccination) was none. Concomitant medications included trazodone (Strength: 25 mg) orally taking for years at 25 mg, once a day for sleep disorder, losartan (Strength: 25 mg) orally taking for 4 years at 25 mg, once a day for blood pressure, acetylsalicylic acid (ASPIRIN) orally taking for 4 years 81 mg, once a day for blood pressure increased, hydroxychloroquine (Strength: 200mg) orally taking for two months at 200 mg, once a day for rheumatoid arthritis, leflunomide (Strength: 10 mg) orally taking for two months at 10 mg, once a day, sertraline orally taking for 4 years at 50 mg, once a day for PTSD (post-traumatic stress disorder); All ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, NDC number: Unknown, Expiration date: Unknown), on 22Mar2021 at 15:30 as a single dose in left arm for COVID-19 Immunization and asthmatic. Family history was none. Prior vaccinations (within 4 weeks) was none. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 she reports developing a headache that has been ongoing since then, 14-16 days total. She also reports fatigue. She has been seen by doctors and had CT scans and bloodwork, the doctors think it was a stress/fatigue headache. Caller indicated she didn't think the symptoms were vaccine related but wants to rule everything out. Enquired what information do we have for duration of headache after vaccination. Caller indicated she had already spoken to a nurse with safety. Caller was a 59-year-old female reporting a headache that started 2 days after her second dose of the Pfizer COVID-19 vaccine, with symptoms that have been ongoing for 14-16 days. Response: Provided information from fact sheet that 55.1% of patients reported headache in the clinical trials, and that data was coming from the 7 days after either dose. Enquired how long side effects last. Which states adverse events typically start 1-2 days after vaccination and resolve shortly thereafter; Also spoke from CDC data which indicates adverse events might be more intense after the second dose. Referred back to healthcare professional for additional assessment and treatment. Consumer calling regarding the Pfizer COVID-19 vaccine. Reports she got the second shot 12Apr2021 and a couple of days later she got pressure in her head that has turned into a major headache. States and it has been a major headache. Reports she has been to the emergency room and her primary care doctor. Adds she had a CT scan, and bloodwork till she looks like a pin cushion, and everything was coming back fine. Adds she was tired all the time and could not get rid of the headache. Her question; Mentions she was looking at the side effects and saw tiredness and headaches a couple of days after; but enquired have we had any complaints about them lasting so long. Clarified she received the second dose of the Pfizer COVID-19 vaccine on 12Apr2021 at 09:30 AM in the left arm. A couple of day later the headache started; and the tiredness started at the same time. Tiredness was reported as worsened. She got the shot at PRIVACY. Adds she has missed two weeks of work and she could sleep 24 hours a day if the headache would let her. Adds she was 60 years old and takes a lot of medication; she tries not. Primary/prescriber: States the rank was major; she thinks her doctor was on maternity leave; Product: Pfizer COVID-19 vaccine; treatment first dose of the vaccine 22Mar2021 at 15:30 PM in the left arm. Lot EN6206; provides lot number for both doses from vaccination card but does not see NDC, expiration date or dose. This past Sunday the headache got so bad that she passed out in her living room and her 72-year-old husband called 911. She was taken to the (PRIVACY) Hospital and they did the CT scan and the blood work that was normal. She went home and tried to go to work on Monday and that only lasted 3 hours. No investigation assessment. No relevant test. The adverse events require a visit to emergency room but not admitted to the hospital and visit to physician office as she saw a doctor at the base on Monday, she had doctor's excuse to be off on Monday and Tuesday, so she called and got a walk-in appointment for Thursday. They did more blood work, and it came out great. The patient underwent lab test and procedure which included blood work: Normal, CT scan: Normal on an unspecified date. The outcome of the event passed out was recovered on an unspecified date in 2021, unknown for the event pressure in her head and not recovered for the other events. No follow-up attempts are needed. No further information is expected. Lot number obtained.
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| 59 | 2021-05-07 | palpitations, loss of consciousness, pallor |
little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a...
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little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
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| 59 | 2021-05-07 | excessive bleeding |
spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn'...
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spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn't call those spots a rash; itching kept her up all night/ She was up all night; rash and welts and the rash was moving up in her face; welts; hands started itching/itching moved up her arms and down her legs and then her whole body was itching; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:30 (Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included high blood pressure and did have surgery in Jan2021, a week before she received the Covid 19 vaccine. She had screws placed in her foot. Her foot had been injured from being twisted too many times. It was an old injury. Concomitant medications included atenolol; omeprazole; venlafaxine; and hydrochlorothiazide, valsartan (VALSARTAN/HCTZ TEVA); all ongoing. Probably about 15 years ago, she received a flu vaccine where her husband worked. His place of employment offered flu vaccines to employees and their families every year. She went to get the flu vaccine and that was probably around 9:00AM and by the time she got off work that day she was so sick with the chills that she crawled into bed. It felt like she had the flu. The next day she felt better just worn out. She hasn't had a flu vaccine since then. She received her first Covid 19 vaccine on 05Feb2021 and about 20 minutes after (05Feb2021 13:50), she received the vaccine her hands started itching and she didn't think a lot about it. As time wore on, the itching moved up her arms and down her legs and then her whole body was itching. By Sunday, 07Feb2021 she had a rash and welts and the rash was moving up in her face. She went to the emergency room on Sunday, 07Feb2021 because the rash was on her face. She was getting scared. She was miserable. She was taking Benadryl and it wasn't doing anything for her. The emergency room gave her a Benadryl injection and liquid steroids and prescribed 2 epinephrine pens (Epi-pens) in case she started to have problems breathing. She did not have trouble breathing. She also received pills to help with her itching. She was still taking those pills because she was still itching. As of 23Apr2021, it was still persisting nothing has improved slightly. It keeps her up at night, making her miserable, and described it as severe. She had spots where she bleeds from scratching. She was up all night two days ago because the itching was so bad. The pills do help but she has to work so she can not take too many or she will be asleep at her desk. Patient hoped that Pfizer would have something to tell her healthcare provider about what to do for her. She was advised by her doctor to not get the second Covid 19 vaccine. She went to her family doctor about a week later and explained what had happened with the Covid 19 vaccine and her doctor was able to review her emergency room visit paperwork. Her primary care doctor prescribed more of the pills for itching because she had gone through the pills that the emergency department prescribed. She reported that the rash has improved but at times, all of a sudden, she'll start itching and it's the type of itching that she can't stop scratching. With scratching it will grow into welts and a rash and then it goes away. She doesn't like to take the pills prescribed for itching because she doesn't like to take medicine. The itching kept her up all night in different parts of her body. The itching will ease down and then the itching will stop and then probably a good hour will pass and the rash will go away. The only thing that was left to see was where she scratched on her body. She still has red spots on her arms that weren't there before. She wouldn't call those spots a rash. The pill she was prescribed for itching is Hydroxyzine 25mg take one by mouth every 6 hours as needed for itching. This one helps but she doesn't want to take it because it can make her tired and she has to work. Outcome of the event "hands started itching/itching moved up her arms and down her legs and then her whole body was itching" was not recovered while unknown for other events.
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| 59 | 2021-05-09 | oxygen saturation decreased, fibrin d dimer increased, pulmonary embolism, heart rate increased |
I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms fo...
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I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms for over 3 weeks prior to hospitalization. I was rapid COVID tested on 3/26/2021 the nurse at CVS asked why my blood oxygen was low. I did not know but had me pant and move my fingers and it went up to 96. I also remember severe leg pain on a drive 3/25/21. I noticed shortness of breath 4/5/21 and fast pulse but didnot go to hospital until 4/18/21. I previously had a PE 7/2009 and also had it for ~2 weeks before going to hospital. I was not on blood thinner since 2015. The doctors at the hospital and primary care doctor did not seem to think the PE was vaccine related but they also do not believe I had symptoms for over 3 weeks.
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| 59 | 2021-05-09 | fast heart rate, increased heart rate, hypotension, blood glucose increased |
o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental s...
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o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic ED COURSE: o ED Course Medical decision making Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic CRITICAL CARE: o Critical Care Indication patient was critically ill... o Critical Care Indication Patient was critically ill with a high probability of imminent or life threatening deterioration. o Critical Care Time Spent 75-104 minutes (1 hour 15 minutes-1 hour 44 minutes) 2 hours and 50 minutes ED WORKING DIAGNOSIS: Perforated abdominal viscus (R19.8): Status: Active Septic shock (A41.9): Status: Active DISCHARGE/ADMISSION/TRANSFER DISPOSITION: o Disposition admitted o Admit To To OR CONDITION ON DISCHARGE/ADMISSION/TRANSFER: o Condition Critical Date of OR Procedure o Date of Procedure 05/10/2021 10:01 Pre Op Dx, Post Op Dx, Procedure o Pre Operative Diagnosis: Perforated viscus o Post Operative Diagnosis: Ischemic bowel, most likely from shower emboli. Most of the small intestine and large intestine was affected. o Procedure: Exploratory laparotomy, ICG injection for evaluation of perfusion Indication and Consent Findings: . Findings: Even after the ICG injection. There was spotty tissue necrosis from mid jejunum all the way through sigmoid colon. Most areas were blackened with a foul smell. There was some highlighted areas secondary to the ICG but not a significant amount that would lend for an anastomosis. Black ascites was present throughout the abdomen. Unfortunately after much contemplation there was no surgical intervention. Procedure Procedure: Patient was placed in supine position. Was intubated in the emergency room so, we were able to proceed with resuscitation through our anesthesia team. Patient's abdomen was prepped and draped in usual fashion. Proceeded to make a midline incision. The blood supply in the subcutaneous tissues did not even bleed. Appeared to be darkened and almost coagulated. As we entered through the fascia we were able to open the peritoneum between 2 hemostats. The large rush of free air through from the abdomen. We then proceeded to open the abdomen for the length of her incision. This was done with electrocautery. From here there was a black ascites present within the abdomen. There was a large amount of dead intestine that we could immediately see. I worked my way to the ligament of Treitz. There was no adhesions so this was easily found. That intestine did appear to be pink. It lasted for about a foot. After that area everything was either black or purple in color with a few pink spots in between. This went all the way down to the terminal ileum where pneumatosis was visualized. We then looked at the colon from cecum through rectum. It appeared to be blackened as well. Not knowing whether all of this intestine was dead or not especially with patient being hypotensive I injected ICG dye approximately 2 cc. This was to evaluate perfusion. Unfortunately perfusion was no better than what I could visualize. I could not even find enough room of the colon or small intestine to make an anastomosis. Was very hard decision, however, we did not resect any bowel. I closed the patient's abdomen. Patient will be taken to ICU on ventilator. Discussed with daughter with pastor present.
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| 59 | 2021-05-10 | deep vein blood clot, pulmonary embolism |
Pulmonary Embolism, in hospital from 4/15 to 4/18, Eliquis DVT Treat 30D, apixaban oral tablets, fam...
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Pulmonary Embolism, in hospital from 4/15 to 4/18, Eliquis DVT Treat 30D, apixaban oral tablets, famotidine chewable tablet, tramadol tablets
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| 59 | 2021-05-10 | pulmonary embolism | Recurrence of PE blood clots in left lung. |